Trial Outcomes & Findings for Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (NCT NCT01078584)

NCT ID: NCT01078584

Last Updated: 2012-10-25

Results Overview

Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg for non-diabetic participants, and SBP/DBP \<130/80 mm Hg for diabetic participants.

• Recruitment status: COMPLETED
• Target enrollment: 7993 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2012-10-25

Participant Flow

A total of 7993 participants were enrolled at 568 study sites in Canada over a period of 24 months.

Although 3 participants were considered to have violated the protocol because they were not adults (ie, </= 18 years old), they were included in the Intention-to-Treat (ITT) cohort.

Participant milestones

Measure	All Enrolled Participants (ITT Cohort) Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Overall Study STARTED	7993
Overall Study Participants Conducted Visit 2 (3-month)	7125
Overall Study Participants Conducted Visit 3 (6-month)	5833
Overall Study Participants Conducted Visit 4(12-month)	4983
Overall Study COMPLETED	4983
Overall Study NOT COMPLETED	3010

Reasons for withdrawal

Measure	All Enrolled Participants (ITT Cohort) Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Overall Study Final Status Unknown	1073
Overall Study Lost to Follow-up	670
Overall Study Non-serious Adverse Event	577
Overall Study Withdrawal of Consent	244
Overall Study Physician Withdrew from Study	90
Overall Study Non-compliance	67
Overall Study Blood Pressure Controlled	49
Overall Study Physician Switched Medication	26
Overall Study Physician Discontinued Patient	12
Overall Study Lack of Efficacy	98
Overall Study Protocol Violation	75
Overall Study Serious Adverse Event	27
Overall Study Multiple Reasons	2

Baseline Characteristics

Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients

Baseline characteristics by cohort

Measure	All Enrolled Participants (ITT Cohort) n=7993 Participants Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Age Continuous	58.3 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex/Gender, Customized Female	3677 participants n=5 Participants
Sex/Gender, Customized Male	4283 participants n=5 Participants
Sex/Gender, Customized Unknown	33 participants n=5 Participants
Region of Enrollment Canada	7993 participants n=5 Participants
Baseline Estimated Glomerular Filtration Rate (eGFR) All Participants (n=3965)	76.9 mL/min STANDARD_DEVIATION 20.3 • n=5 Participants
Baseline Estimated Glomerular Filtration Rate (eGFR) Diabetic Participants (n=1178)	77.7 mL/min STANDARD_DEVIATION 24.2 • n=5 Participants
Baseline Microalbuminuria (MAU) All Participants (n=2476)	36.5 mg/L STANDARD_DEVIATION 142.2 • n=5 Participants
Baseline Microalbuminuria (MAU) Diabetic Participants (n=1009)	55.1 mg/L STANDARD_DEVIATION 191.5 • n=5 Participants
Baseline Systolic Blood Pressure (SBP) All Participants (n=7992)	150.8 mm Hg STANDARD_DEVIATION 15.6 • n=5 Participants
Baseline Systolic Blood Pressure (SBP) Diabetic Participants (n=1883)	145.8 mm Hg STANDARD_DEVIATION 15.7 • n=5 Participants
Baseline Systolic Blood Pressure (SBP) Renal Dysfunction Participants (n=196)	147.6 mm Hg STANDARD_DEVIATION 17.1 • n=5 Participants
Baseline Systolic Blood Pressure (SBP) ISH Participants (n=2207)	153.0 mm Hg STANDARD_DEVIATION 10.9 • n=5 Participants
Baseline Diastolic Blood Pressure (DBP) All Participants (n=7991)	89.7 mm Hg STANDARD_DEVIATION 10.7 • n=5 Participants
Baseline Diastolic Blood Pressure (DBP) Diabetic Participants (n=1883)	85.7 mm Hg STANDARD_DEVIATION 10.5 • n=5 Participants
Baseline Diastolic Blood Pressure (DBP) Renal Dysfunction Participants (n=196)	83.0 mm Hg STANDARD_DEVIATION 12.0 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).

Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.

Outcome measures

Measure	Non-Diabetic Cohort n=5275 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=1605 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months	56.0 percentage of participants Interval 54.6 to 57.3	28.2 percentage of participants Interval 26.0 to 30.4	—	—

PRIMARY outcome

Timeframe: 6 months

Population: Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).

Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.

Outcome measures

Measure	Non-Diabetic Cohort n=4374 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=1347 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months	66.2 percentage of participants Interval 64.8 to 67.6	31.1 percentage of participants Interval 28.6 to 33.6	—	—

PRIMARY outcome

Timeframe: 12 months

Population: Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).

Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.

Outcome measures

Measure	Non-Diabetic Cohort n=3751 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=1174 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months	72.9 percentage of participants Interval 71.5 to 74.3	34.4 percentage of participants Interval 31.7 to 37.1	—	—

SECONDARY outcome

Timeframe: Baseline, 3 Months

Population: Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).

Diabetics were considered to be "BP-controlled" if BP <130/80 mm Hg. Diabetics were considered to be "BP-uncontrolled" if BP >/=130/80 mm Hg.

Outcome measures

Measure	Non-Diabetic Cohort n=472 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=153 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled n=319 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months	0.7 mL/min Interval -2.9 to 4.3	-1.5 mL/min Interval -3.2 to 0.3	1.7 mL/min Interval -3.6 to 7.0	—

SECONDARY outcome

Timeframe: Baseline, 6 Months

Population: Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).

Diabetics were considered to be "BP-controlled" if BP <130/80 mm Hg. Diabetics were considered to be "BP-uncontrolled" if BP >/=130/80 mm Hg.

Outcome measures

Measure	Non-Diabetic Cohort n=399 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=133 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled n=266 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months	0.0 mL/min Interval -1.2 to 1.2	0.7 mL/min Interval -1.2 to 2.7	-0.4 mL/min Interval -1.9 to 1.1	—

SECONDARY outcome

Timeframe: Baseline,12 Months

Population: Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).

Diabetics were considered to be "BP-controlled" if BP <130/80 mm Hg. Diabetics were considered to be "BP-uncontrolled" if BP >/=130/80 mm Hg.

Outcome measures

Measure	Non-Diabetic Cohort n=409 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=148 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled n=261 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months	0.8 mL/min Interval -0.6 to 2.3	1.5 mL/min Interval -1.3 to 4.3	0.4 mL/min Interval -1.2 to 2.1	—

SECONDARY outcome

Timeframe: Baseline, 3 Months

Population: Evaluable participants (all participants in the ITT cohort with MAU measurement at given time point).

Outcome measures

Measure	Non-Diabetic Cohort n=764 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Change From Baseline in Microalbuminuria (MAU) at 3 Months	-6.8 mg/L Interval -17.2 to 3.6	—	—	—

SECONDARY outcome

Timeframe: Baseline, 6 Months

Population: Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point).

Outcome measures

Measure	Non-Diabetic Cohort n=652 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Change From Baseline in Microalbuminuria (MAU) at 6 Months	-5.3 mg/L Interval -16.0 to 5.3	—	—	—

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point).

Outcome measures

Measure	Non-Diabetic Cohort n=717 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Change From Baseline in Microalbuminuria (MAU) at 12 Months	-6.9 mg/L Interval -15.9 to 2.0	—	—	—

SECONDARY outcome

Timeframe: 3 Months

Population: Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).

The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as "controlled."

Outcome measures

Measure	Non-Diabetic Cohort n=1953 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy	58.4 percentage of participants Interval 56.2 to 60.6	—	—	—

SECONDARY outcome

Timeframe: 6 Months

Population: Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).

The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as "controlled."

Outcome measures

Measure	Non-Diabetic Cohort n=1617 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy	67.6 percentage of participants Interval 65.3 to 69.9	—	—	—

SECONDARY outcome

Timeframe: 12 Months

Population: Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).

The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as "controlled."

Outcome measures

Measure	Non-Diabetic Cohort n=1420 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy	74.2 percentage of participants Interval 71.9 to 76.4	—	—	—

SECONDARY outcome

Timeframe: Day 0 (Baseline), 12 months

Population: ITT cohort. n=evaluable participants from the ITT cohort who answered the satisfaction questions at Baseline and 12-Month visits.

Satisfaction with therapy at baseline (BL) and 12 months, using a 5-point Likert scale where participants responded to the question "Are you satisfied with your current hypertension therapy?". The range of responses varied from "1 = not at all satisfied" to "5 = extremely satisfied." Responses "2" through "4" were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively.

Outcome measures

Measure	Non-Diabetic Cohort n=7993 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy Score=1 at BL (n=7212)	28.4 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy Score=2 at BL (n=7212)	26.8 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy Score=3 at BL (n=7212)	30.7 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy Score=4 at BL (n=7212)	10.3 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy Score=5 at BL (n=7212)	3.8 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy Score=1 at 12 Months (n=4928)	1.8 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy Score=2 at 12 Months (n=4928)	3.5 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy Score=3 at 12 Months (n=4928)	9.4 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy Score=4 at 12 Months (n=4928)	33.6 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy Score=5 at 12 Months (n=4928)	51.7 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 0 (Baseline), 12 months

Population: Subset of participants from the ITT cohort who answered the satisfaction questions at both the Baseline and 12-Month visits.

Satisfaction with therapy at baseline (BL) versus 12 months, using a 5-point Likert scale where participants responded to the question "Are you satisfied with your current hypertension therapy?". The range of responses varied from "1 = not at all satisfied" to "5 = extremely satisfied." Responses "2" through "4" were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively.

Outcome measures

Measure	Non-Diabetic Cohort n=4510 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=1 (at BL) / Score=1 (at 12 Months)	0.62 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=1 (at BL) / Score=2 (at 12 Months)	0.67 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=1 (at BL) / Score=3 (at 12 Months)	2.33 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=1 (at BL) / Score=4 (at 12 Months)	8.36 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=1 (at BL) / Score=5 (at 12 Months)	15.63 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=2 (at BL) / Score=1 (at 12 Months)	0.42 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=2 (at BL) / Score=2 (at 12 Months)	1.82 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=2 (at BL) / Score=3 (at 12 Months)	2.71 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=2 (at BL) / Score=4 (at 12 Months)	9.84 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=2 (at BL) / Score=5 (at 12 Months)	11.82 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=3 (at BL) / Score=1 (at 12 Months)	0.53 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=3 (at BL) / Score=2 (at 12 Months)	0.89 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=3 (at BL) / Score=3 (at 12 Months)	3.90 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=3 (at BL) / Score=4 (at 12 Months)	12.06 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=3 (at BL) / Score=5 (at 12 Months)	13.86 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=4 (at BL) / Score=1 (at 12 Months)	0.07 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=4 (at BL) / Score=2 (at 12 Months)	0.09 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=4 (at BL) / Score=3 (at 12 Months)	0.53 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=4 (at BL) / Score=4 (at 12 Months)	4.12 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=4 (at BL) / Score=5 (at 12 Months)	5.96 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=5 (at BL) / Score=1 (at 12 Months)	0.07 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=5 (at BL) / Score=2 (at 12 Months)	0.07 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=5 (at BL) / Score=3 (at 12 Months)	0.29 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=5 (at BL) / Score=4 (at 12 Months)	0.67 percentage of participants	—	—	—
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy Score=5 (at BL) / Score=5 (at 12 Months)	2.68 percentage of participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

Population: Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).

Blood Pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."

Outcome measures

Measure	Non-Diabetic Cohort n=6880 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Participants Achieving 2008 CHEP Targets After 3 Months of Therapy	58.3 percentage of participants Interval 57.1 to 59.4	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Population: Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).

Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."

Outcome measures

Measure	Non-Diabetic Cohort n=5721 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Participants Achieving 2008 CHEP Targets After 6 Months of Therapy	68.1 percentage of participants Interval 66.9 to 69.3	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).

Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."

Outcome measures

Measure	Non-Diabetic Cohort n=4925 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Participants Achieving 2008 CHEP Targets After 12 Months of Therapy	74.4 percentage of participants Interval 73.2 to 75.6	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

Population: Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).

Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."

Outcome measures

Measure	Non-Diabetic Cohort n=172 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 3 Months of Therapy	29.1 percentage of participants Interval 22.3 to 35.9	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Population: Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).

Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."

Outcome measures

Measure	Non-Diabetic Cohort n=131 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 6 Months of Therapy	31.3 percentage of participants Interval 23.4 to 39.2	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).

Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."

Outcome measures

Measure	Non-Diabetic Cohort n=112 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 12 Months of Therapy	36.6 percentage of participants Interval 27.7 to 45.5	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (Baseline), 3 Months

Population: ITT cohort. n = all evaluable participants in the ITT cohort with blood pressure measurement at given timepoint.

Outcome measures

Measure	Non-Diabetic Cohort n=7993 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months SBP (n=6881)	-16.5 mm Hg Interval -16.9 to -16.1	—	—	—
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months DBP (n=6880)	-8.4 mm Hg Interval -8.7 to -8.2	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (Baseline), 6 Months

Population: Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).

Outcome measures

Measure	Non-Diabetic Cohort n=5721 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months SBP	-18.7 mm Hg Interval -19.2 to -18.3	—	—	—
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months DBP	-9.7 mm Hg Interval -10.8 to -9.4	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (Baseline), 12 Months

Population: Evaluable participants (participants in the ITT cohort with blood pressure measurements at given timepoint).

Outcome measures

Measure	Non-Diabetic Cohort n=4925 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months SBP	-20.1 mm Hg Interval -20.6 to -19.6	—	—	—
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months DBP	-10.5 mm Hg Interval -10.8 to -10.2	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (Baseline)

Population: Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).

Outcome measures

Measure	Non-Diabetic Cohort n=6108 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=1883 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled n=2207 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort n=196 Participants The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts SBP	152.4 mm Hg Interval 152.0 to 152.8	145.8 mm Hg Interval 145.1 to 146.5	153.3 mm Hg Interval 152.9 to 153.8	147.6 mm Hg Interval 145.2 to 150.0
Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts DBP	90.9 mm Hg Interval 90.7 to 91.2	85.7 mm Hg Interval 85.2 to 86.1	80.2 mm Hg Interval 79.9 to 80.4	83.0 mm Hg Interval 81.3 to 84.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (Baseline), Month 3

Population: Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).

Outcome measures

Measure	Non-Diabetic Cohort n=5275 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=1605 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled n=1953 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort n=172 Participants The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 SBP	-17.4 mm Hg Interval -17.8 to -16.9	-13.6 mm Hg Interval -14.4 to -12.8	-17.2 mm Hg Interval -17.9 to -16.5	-14.8 mm Hg Interval -17.6 to -12.1
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3 DBP	-8.8 mm Hg Interval -9.1 to -8.5	-7.0 mm Hg Interval -7.5 to -6.5	-2.5 mm Hg Interval -2.9 to -2.1	-6.9 mm Hg Interval -8.7 to -5.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (Baseline), Month 6

Population: Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).

Outcome measures

Measure	Non-Diabetic Cohort n=4374 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=1347 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled n=1617 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort n=131 Participants The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 SBP	-19.8 mm Hg Interval -20.3 to -19.3	-15.3 mm Hg Interval -16.1 to -14.4	-19.2 mm Hg Interval -19.9 to -18.4	-17.5 mm Hg Interval -20.6 to -14.3
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6 DBP	-10.3 mm Hg Interval -10.6 to -9.9	-7.9 mm Hg Interval -8.4 to -7.3	-2.9 mm Hg Interval -3.4 to -2.5	-8.2 mm Hg Interval -10.2 to -6.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (Baseline), Month 12

Population: Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).

Outcome measures

Measure	Non-Diabetic Cohort n=3751 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=1174 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled n=1420 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort n=112 Participants The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 SBP	-21.2 mm Hg Interval -21.7 to -20.6	-16.7 mm Hg Interval -17.6 to -15.7	-20.5 mm Hg Interval -21.2 to -19.7	-18.3 mm Hg Interval -21.8 to -14.8
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12 DBP	-11.0 mm Hg Interval -11.4 to -10.7	-8.8 mm Hg Interval -9.4 to -8.2	-3.6 mm Hg Interval -4.0 to -3.1	-9.7 mm Hg Interval -11.8 to -7.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

Population: Evaluable participants (participants in the ITT cohort with compliance data available at given time point).

Compliance after 3 months of treatment was derived using responses to the Visit 2 question "How many trandolapril (Mavik®) doses have been missed since the subject's last visit?" If the response was "zero", the participant was classified as "compliant." If the response was any value greater than zero, regardless of the number of missed doses, the participant was classified as "non-compliant."

Outcome measures

Measure	Non-Diabetic Cohort n=6716 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Number of Participants Compliant With Therapy After 3 Months	5015 participants Interval 73.6 to 75.7	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Population: Evaluable participants (participants in the ITT cohort with compliance data available at given time point).

Compliance after 6 months of treatment was derived using responses to the question "How many trandolapril (Mavik®) doses have been missed since the subject's last visit?" at both Visit 2 and Visit 3, as follows: If the response was "zero" at both the Visit 2 and Visit 3 assessments, participant was classified as "compliant" after 6 months of treatment; If the response was any value greater than zero at either of the Visit 2 or Visit 3 assessments, regardless of the number of missed doses, participant was classified as "non-compliant" after 6 months of treatment

Outcome measures

Measure	Non-Diabetic Cohort n=5588 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Number of Participants Compliant With Therapy After 6 Months	3661 participants Interval 64.3 to 66.8	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Evaluable participants (participants in the ITT cohort with compliance data available at given time point).

Compliance after 12 months of treatment was derived using responses to the question "How many trandolapril doses have been missed since the subject's last visit?" at Visit 2, Visit 3 and Visit 4, as follows: if the response was "zero" at all of the Visits 2 through 4 assessments, the participant was classified as "compliant" after 12 months of treatment; if the response was any value greater than zero at any of the Visits 2 through 4 assessments, regardless of the number of missed doses, the participant was classified as "non-compliant" after 12 months of treatment.

Outcome measures

Measure	Non-Diabetic Cohort n=4728 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Number of Participants Compliant With Therapy After 12 Months	2793 participants Interval 57.7 to 60.5	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

Population: Evaluable participants (all participants in the ITT cohort with data available at given time point).

Outcome measures

Measure	Non-Diabetic Cohort n=6456 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Number of Participants With Dose Changes at 3 Months Dose Decreased	173 participants	—	—	—
Number of Participants With Dose Changes at 3 Months Dose Increased	1868 participants	—	—	—
Number of Participants With Dose Changes at 3 Months No Change in Dose	4373 participants	—	—	—
Number of Participants With Dose Changes at 3 Months Unknown	42 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Population: Evaluable participants (all participants in the ITT cohort with data available at given time point).

Outcome measures

Measure	Non-Diabetic Cohort n=5519 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Number of Participants With Dose Changes at 6 Months Dose Decreased	125 participants	—	—	—
Number of Participants With Dose Changes at 6 Months Dose Increased	578 participants	—	—	—
Number of Participants With Dose Changes at 6 Months No Change in Dose	4735 participants	—	—	—
Number of Participants With Dose Changes at 6 Months Unknown	81 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Evaluable participants (all participants in the ITT cohort with data available at given time point).

Outcome measures

Measure	Non-Diabetic Cohort n=4770 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Number of Participants With Dose Changes at 12 Months Dose Decreased	100 participants	—	—	—
Number of Participants With Dose Changes at 12 Months Dose Increased	370 participants	—	—	—
Number of Participants With Dose Changes at 12 Months No Change in Dose	4196 participants	—	—	—
Number of Participants With Dose Changes at 12 Months Unknown	104 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

Population: Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).

The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented.

Outcome measures

Measure	Non-Diabetic Cohort n=2115 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=2760 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled n=1077 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort n=413 Participants The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months Dose Increase	46.7 percentage of participants	17.9 percentage of participants	31.4 percentage of participants	10.4 percentage of participants
Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months No Dose Increase	53.3 percentage of participants	82.1 percentage of participants	68.6 percentage of participants	89.6 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Population: Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).

The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented.

Outcome measures

Measure	Non-Diabetic Cohort n=1357 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=2785 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled n=870 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort n=406 Participants The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months Dose Increase	23.1 percentage of participants	4.9 percentage of participants	12.1 percentage of participants	5.4 percentage of participants
Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months No Dose Increase	76.9 percentage of participants	95.1 percentage of participants	87.9 percentage of participants	94.6 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).

The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented.

Outcome measures

Measure	Non-Diabetic Cohort n=912 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=2630 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled n=712 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort n=393 Participants The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months Dose Increase	15.7 percentage of participants	5.2 percentage of participants	9.6 percentage of participants	4.8 percentage of participants
Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months No Dose Increase	84.3 percentage of participants	94.8 percentage of participants	90.4 percentage of participants	95.2 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

Population: Evaluable participants (all participants in the ITT cohort with available data at given time point).

Presented by type of medication added.

Outcome measures

Measure	Non-Diabetic Cohort n=7125 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months None	6090 participants	—	—	—
Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months Diuretic	284 participants	—	—	—
Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months Angiotensin receptor blocker	133 participants	—	—	—
Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months Calcium channel blocker	186 participants	—	—	—
Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months Beta-blocker	78 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Population: Evaluable participants (all participants in the ITT cohort with available data at given time point).

Presented by type of medication added.

Outcome measures

Measure	Non-Diabetic Cohort n=5833 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months None	5193 participants	—	—	—
Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months Diuretic	222 participants	—	—	—
Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months Angiotensin receptor blocker	82 participants	—	—	—
Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months Calcium channel blocker	123 participants	—	—	—
Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months Beta-blocker	41 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Evaluable participants (all participants in the ITT cohort with available data at given time point).

Presented by type of medication added.

Outcome measures

Measure	Non-Diabetic Cohort n=4983 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months None	4540 participants	—	—	—
Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months Diuretic	144 participants	—	—	—
Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months Angiotensin receptor blocker	61 participants	—	—	—
Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months Calcium channel blocker	86 participants	—	—	—
Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months Beta-blocker	35 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

Population: Evaluable participants (all participants in the ITT cohort with available data at given time point).

Presented by type of medication discontinued.

Outcome measures

Measure	Non-Diabetic Cohort n=7125 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months None	6656 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months Diuretic	27 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months Angiotensin-converting-enzyme inhibitor	4 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months Angiotensin receptor blocker	6 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months Calcium channel blocker	22 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months Beta-blocker	20 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Population: Evaluable participants (all participants in the ITT cohort with available data at given time point).

Presented by type of medication discontinued.

Outcome measures

Measure	Non-Diabetic Cohort n=5833 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months None	5607 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months Diuretic	24 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months Angiotensin-converting-enzyme inhibitor	4 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months Angiotensin receptor blocker	4 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months Calcium channel blocker	17 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months Beta-blocker	8 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Evaluable participants (all participants in the ITT cohort with available data at given time point).

Presented by type of medication discontinued.

Outcome measures

Measure	Non-Diabetic Cohort n=4983 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months None	4823 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months Diuretic	25 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months Angiotensin-converting-enzyme inhibitor	2 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months Angiotensin receptor blocker	3 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months Calcium channel blocker	10 participants	—	—	—
Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months Beta-blocker	6 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

Population: Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point).

Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled."

Outcome measures

Measure	Non-Diabetic Cohort n=1605 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=172 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 3 Months	65.7 percentage of participants Interval 63.4 to 68.0	66.3 percentage of participants Interval 59.2 to 73.3	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Population: Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with blood pressure measurement at given time point).

Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled."

Outcome measures

Measure	Non-Diabetic Cohort n=1347 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=131 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 6 Months	74.1 percentage of participants Interval 71.8 to 76.4	70.2 percentage of participants Interval 62.4 to 78.1	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point).

Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled."

Outcome measures

Measure	Non-Diabetic Cohort n=1174 Participants The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort n=112 Participants The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.	Diabetic Cohort: BP-Uncontrolled The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP \>/=130/80 mm Hg.	Renal Dysfunction Cohort The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of "renal dysfunction" was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 12 Months	79.2 percentage of participants Interval 76.9 to 81.5	75.0 percentage of participants Interval 67.0 to 83.0	—	—

Adverse Events

All Enrolled Participants (ITT Cohort)

Serious events: 83 serious events

Other events: 527 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Enrolled Participants (ITT Cohort) n=7993 participants at risk Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
Infections and infestations pneumonia	0.04% 3/7993 • Day 0 to Day 360
Infections and infestations sepsis	0.04% 3/7993 • Day 0 to Day 360
Infections and infestations gangrene	0.01% 1/7993 • Day 0 to Day 360
Infections and infestations lung infection	0.01% 1/7993 • Day 0 to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) lung neoplasm malignant	0.04% 3/7993 • Day 0 to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) metastatic neoplasm	0.03% 2/7993 • Day 0 to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) breast cancer	0.03% 2/7993 • Day 0 to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) adenocarcinoma	0.01% 1/7993 • Day 0 to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) colon cancer	0.01% 1/7993 • Day 0 to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) endometrial cancer	0.01% 1/7993 • Day 0 to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) hepatic neoplasm	0.01% 1/7993 • Day 0 to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) lung cancer metastatic	0.01% 1/7993 • Day 0 to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) lung squamous cell carcinoma stage unspecified	0.01% 1/7993 • Day 0 to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) metastases to bone	0.01% 1/7993 • Day 0 to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) multiple myeloma	0.01% 1/7993 • Day 0 to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neoplasm malignant	0.01% 1/7993 • Day 0 to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps) pancreatic carcinoma	0.01% 1/7993 • Day 0 to Day 360
Immune system disorders amyloidosis	0.01% 1/7993 • Day 0 to Day 360
Endocrine disorders hypothyroidism	0.01% 1/7993 • Day 0 to Day 360
Metabolism and nutrition disorders diabetes mellitus	0.03% 2/7993 • Day 0 to Day 360
Metabolism and nutrition disorders hyponatraemia	0.01% 1/7993 • Day 0 to Day 360
Psychiatric disorders alcoholism	0.01% 1/7993 • Day 0 to Day 360
Psychiatric disorders completed suicide	0.01% 1/7993 • Day 0 to Day 360
Psychiatric disorders schizophrenia	0.01% 1/7993 • Day 0 to Day 360
Nervous system disorders cerebrovascular accident	0.06% 5/7993 • Day 0 to Day 360
Nervous system disorders dizziness	0.04% 3/7993 • Day 0 to Day 360
Nervous system disorders syncope	0.01% 1/7993 • Day 0 to Day 360
Nervous system disorders carotid artery stenosis	0.01% 1/7993 • Day 0 to Day 360
Nervous system disorders cerebral hematoma	0.01% 1/7993 • Day 0 to Day 360
Nervous system disorders coma	0.01% 1/7993 • Day 0 to Day 360
Nervous system disorders dementia	0.01% 1/7993 • Day 0 to Day 360
Nervous system disorders loss of consciousness	0.01% 1/7993 • Day 0 to Day 360
Nervous system disorders quadriplegia	0.01% 1/7993 • Day 0 to Day 360
Nervous system disorders transient ischemic attack	0.01% 1/7993 • Day 0 to Day 360
Nervous system disorders VIIth nerve paralysis	0.01% 1/7993 • Day 0 to Day 360
Eye disorders eye haemorrhage	0.01% 1/7993 • Day 0 to Day 360
Eye disorders ocular vascular disorder	0.01% 1/7993 • Day 0 to Day 360
Eye disorders visual acuity reduced	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders myocardial infarction	0.10% 8/7993 • Day 0 to Day 360
Cardiac disorders atrial fibrillation	0.06% 5/7993 • Day 0 to Day 360
Cardiac disorders angina pectoris	0.05% 4/7993 • Day 0 to Day 360
Cardiac disorders cardiac arrest	0.04% 3/7993 • Day 0 to Day 360
Cardiac disorders cardiac failure	0.04% 3/7993 • Day 0 to Day 360
Cardiac disorders cardiac failure congestive	0.04% 3/7993 • Day 0 to Day 360
Cardiac disorders acute coronary syndrome	0.03% 2/7993 • Day 0 to Day 360
Cardiac disorders cardiac disorder	0.03% 2/7993 • Day 0 to Day 360
Cardiac disorders coronary artery disease	0.03% 2/7993 • Day 0 to Day 360
Cardiac disorders coronary artery stenosis	0.03% 2/7993 • Day 0 to Day 360
Cardiac disorders palpitations	0.03% 2/7993 • Day 0 to Day 360
Cardiac disorders ventricular hypokinesis	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders arteriosclerosis coronary artery	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders atrioventricular block	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders bradycardia	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders cardiac tamponade	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders cardiogenic shock	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders cardio-respiratory arrest	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders coronary artery occlusion	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders coronary artery thrombosis	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders left ventricular dysfunction	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders left ventricular hypertrophy	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders mitral valve disease	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders mitral valve incompetence	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders myocardial ischemia	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders pericardial haemorrhage	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders right ventricular dysfunction	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders sick sinus syndrome	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders supraventricular tachycardia	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders torsade de pointes	0.01% 1/7993 • Day 0 to Day 360
Cardiac disorders ventricular fibrillation	0.01% 1/7993 • Day 0 to Day 360
Vascular disorders infarction	0.03% 2/7993 • Day 0 to Day 360
Vascular disorders aortic aneurysm	0.01% 1/7993 • Day 0 to Day 360
Vascular disorders arterial occlusive disease	0.01% 1/7993 • Day 0 to Day 360
Vascular disorders arteriosclerosis	0.01% 1/7993 • Day 0 to Day 360
Vascular disorders blood pressure inadequately controlled	0.01% 1/7993 • Day 0 to Day 360
Vascular disorders hypotension	0.01% 1/7993 • Day 0 to Day 360
Vascular disorders peripheral ischaemia	0.01% 1/7993 • Day 0 to Day 360
Vascular disorders peripheral vascular disease	0.01% 1/7993 • Day 0 to Day 360
Vascular disorders shock	0.01% 1/7993 • Day 0 to Day 360
Respiratory, thoracic and mediastinal disorders dyspnoea	0.06% 5/7993 • Day 0 to Day 360
Vascular disorders pulmonary oedema	0.04% 3/7993 • Day 0 to Day 360
Respiratory, thoracic and mediastinal disorders cough	0.03% 2/7993 • Day 0 to Day 360
Respiratory, thoracic and mediastinal disorders respiratory failure	0.03% 2/7993 • Day 0 to Day 360
Respiratory, thoracic and mediastinal disorders chronic obstructive pulmonary disease	0.01% 1/7993 • Day 0 to Day 360
Respiratory, thoracic and mediastinal disorders dyspnoea exertional	0.01% 1/7993 • Day 0 to Day 360
Respiratory, thoracic and mediastinal disorders pneumothorax	0.01% 1/7993 • Day 0 to Day 360
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.01% 1/7993 • Day 0 to Day 360
Respiratory, thoracic and mediastinal disorders respiratory arrest	0.01% 1/7993 • Day 0 to Day 360
Gastrointestinal disorders abdominal pain	0.03% 2/7993 • Day 0 to Day 360
Gastrointestinal disorders pancreatitis acute	0.03% 2/7993 • Day 0 to Day 360
Gastrointestinal disorders ascites	0.01% 1/7993 • Day 0 to Day 360
Gastrointestinal disorders colitis iscaemic	0.01% 1/7993 • Day 0 to Day 360
Gastrointestinal disorders gastric ulcer	0.01% 1/7993 • Day 0 to Day 360
Gastrointestinal disorders gastroesophageal reflux disease	0.01% 1/7993 • Day 0 to Day 360
Gastrointestinal disorders hiatus hernia	0.01% 1/7993 • Day 0 to Day 360
Gastrointestinal disorders lip swelling	0.01% 1/7993 • Day 0 to Day 360
Gastrointestinal disorders oedema mouth	0.01% 1/7993 • Day 0 to Day 360
Gastrointestinal disorders swollen tongue	0.01% 1/7993 • Day 0 to Day 360
Skin and subcutaneous tissue disorders angioedema	0.01% 1/7993 • Day 0 to Day 360
Musculoskeletal and connective tissue disorders pain in extremity	0.03% 2/7993 • Day 0 to Day 360
Musculoskeletal and connective tissue disorders lower extremity mass	0.01% 1/7993 • Day 0 to Day 360
Musculoskeletal and connective tissue disorders mobility decreased	0.01% 1/7993 • Day 0 to Day 360
Renal and urinary disorders renal failure	0.03% 2/7993 • Day 0 to Day 360
Renal and urinary disorders glomerulonephritis membranous	0.01% 1/7993 • Day 0 to Day 360
Renal and urinary disorders oliguria	0.01% 1/7993 • Day 0 to Day 360
Renal and urinary disorders proteinuria	0.01% 1/7993 • Day 0 to Day 360
Renal and urinary disorders renal failure acute	0.01% 1/7993 • Day 0 to Day 360
Reproductive system and breast disorders post-menopausal haemorrhage	0.01% 1/7993 • Day 0 to Day 360
General disorders death	0.06% 5/7993 • Day 0 to Day 360
General disorders chest pain	0.05% 4/7993 • Day 0 to Day 360
General disorders asthenia	0.04% 3/7993 • Day 0 to Day 360
General disorders fatigue	0.03% 2/7993 • Day 0 to Day 360
General disorders oedema peripheral	0.03% 2/7993 • Day 0 to Day 360
General disorders chest discomfort	0.01% 1/7993 • Day 0 to Day 360
General disorders malaise	0.01% 1/7993 • Day 0 to Day 360
General disorders terminal state	0.01% 1/7993 • Day 0 to Day 360
Investigations weight decreased	0.03% 2/7993 • Day 0 to Day 360
Investigations blood pressure decreased	0.01% 1/7993 • Day 0 to Day 360
Injury, poisoning and procedural complications fall	0.05% 4/7993 • Day 0 to Day 360
Injury, poisoning and procedural complications hip fracture	0.03% 2/7993 • Day 0 to Day 360
Injury, poisoning and procedural complications post-procedural complication	0.03% 2/7993 • Day 0 to Day 360
Injury, poisoning and procedural complications road traffic accident	0.03% 2/7993 • Day 0 to Day 360
Injury, poisoning and procedural complications complications of transplanted liver	0.01% 1/7993 • Day 0 to Day 360
Injury, poisoning and procedural complications femur fracture	0.01% 1/7993 • Day 0 to Day 360
Injury, poisoning and procedural complications foot fracture	0.01% 1/7993 • Day 0 to Day 360
Injury, poisoning and procedural complications injury	0.01% 1/7993 • Day 0 to Day 360
Injury, poisoning and procedural complications lower limb fracture	0.01% 1/7993 • Day 0 to Day 360
Injury, poisoning and procedural complications rib fracture	0.01% 1/7993 • Day 0 to Day 360
Surgical and medical procedures pericardial drainage	0.01% 1/7993 • Day 0 to Day 360
Surgical and medical procedures aortic valve replacement	0.01% 1/7993 • Day 0 to Day 360
Surgical and medical procedures cardiac pacemaker insertion	0.01% 1/7993 • Day 0 to Day 360
Surgical and medical procedures hernia hiatus repair	0.01% 1/7993 • Day 0 to Day 360
Surgical and medical procedures hospitalization	0.01% 1/7993 • Day 0 to Day 360
Surgical and medical procedures knee arthroplasty	0.01% 1/7993 • Day 0 to Day 360
Surgical and medical procedures rotator cuff repair	0.01% 1/7993 • Day 0 to Day 360
Social circumstances homicide	0.01% 1/7993 • Day 0 to Day 360

Other adverse events

Measure

All Enrolled Participants (ITT Cohort) n=7993 participants at risk Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.

Respiratory, thoracic and mediastinal disorders cough

6.6% 527/7993 • Day 0 to Day 360

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER