Trial Outcomes & Findings for TELMA - Observational Study in Daily Medical Practice of the Effectiveness of Telmisartan for Treatment of Hypertension in Patients With and Without Confirmed Albuminuria in Belgium (NCT NCT00886288)

NCT ID: NCT00886288

Last Updated: 2014-06-17

Results Overview

Systolic blood pressure (SBP) \< 140 mmHg and diastolic blood pressure (DBP) \< 90 mmHg if the patient has: * no chronic renal insufficiency or macroalbuminuria-dipsticks negative, * albuminuria is \< 300 mg/24h or \< 200 mg albumin per gram of creatinine * no diabetes or SBP \< 130 mmHg and DBP \< 80 mmHg if the patient has: * chronic renal insufficiency or macroalbuminuria-dipsticks are positive, albuminuria ≥ 300 mg/24h or ≥ 200 mg albumin per gram of creatinine * diabetes (type 1 or 2)

Recruitment status

COMPLETED

Target enrollment

2874 participants

Primary outcome timeframe

approximately 12 weeks (10 to 14 weeks) after baseline

Results posted on

2014-06-17

Participant Flow

163 patients without information on albuminuria at baseline were enrolled to the study in addition. However, for these patients information on study completion is not available.

Participant milestones

Participant milestones
Measure	Patients Without Albuminuria Treated With Telmisartan	Patients With Albuminuria Treated With Telmisartan
Overall Study STARTED	2027	684
Overall Study COMPLETED	1284	457
Overall Study NOT COMPLETED	743	227

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Without Albuminuria Treated With Telmisartan	Patients With Albuminuria Treated With Telmisartan
Overall Study no respect of the 12 weeks period	657	227
Overall Study Lost to Follow-up	86	0

Baseline Characteristics

TELMA - Observational Study in Daily Medical Practice of the Effectiveness of Telmisartan for Treatment of Hypertension in Patients With and Without Confirmed Albuminuria in Belgium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Without Albuminuria Treated With Telmisartan n=2027 Participants baseline population	Patients With Albuminuria Treated With Telmisartan n=684 Participants baseline population	Total n=2711 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 11.7 • n=5 Participants	65.9 years STANDARD_DEVIATION 11.9 • n=7 Participants	63.8 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	966 Participants n=5 Participants	329 Participants n=7 Participants	1295 Participants n=5 Participants
Sex: Female, Male Male	1061 Participants n=5 Participants	355 Participants n=7 Participants	1416 Participants n=5 Participants

PRIMARY outcome

Timeframe: approximately 12 weeks (10 to 14 weeks) after baseline

Population: 1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)

Systolic blood pressure (SBP) \< 140 mmHg and diastolic blood pressure (DBP) \< 90 mmHg if the patient has: * no chronic renal insufficiency or macroalbuminuria-dipsticks negative, * albuminuria is \< 300 mg/24h or \< 200 mg albumin per gram of creatinine * no diabetes or SBP \< 130 mmHg and DBP \< 80 mmHg if the patient has: * chronic renal insufficiency or macroalbuminuria-dipsticks are positive, albuminuria ≥ 300 mg/24h or ≥ 200 mg albumin per gram of creatinine * diabetes (type 1 or 2)

Outcome measures

Outcome measures
Measure	Patients Without Albuminuria Treated With Telmisartan n=1281 Participants	Patients With Albuminuria Treated With Telmisartan n=457 Participants
Percentage of Patients With Controlled Blood Pressure	46.1 Percentage of patients 1.39	24.1 Percentage of patients 2

SECONDARY outcome

Timeframe: baseline and approximately 12 weeks

Population: 1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)

The fall in systolic blood pressure (SBP) after approximately 12 weeks of treatment including telmisartan defined as SBP (baseline) - SBP (12 weeks) expressed in mmHg

Outcome measures

Outcome measures
Measure	Patients Without Albuminuria Treated With Telmisartan n=1281 Participants	Patients With Albuminuria Treated With Telmisartan n=457 Participants
Mean Difference in Systolic Blood Pressure	20.8 mmHg Standard Deviation 13.3	20.5 mmHg Standard Deviation 13.0

SECONDARY outcome

Timeframe: baseline and approximately 12 weeks

Population: 1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)

The fall in diastolic blood pressure (DBP) after approximately 12 weeks of treatment including telmisartan defined as DBP (baseline) - DBP (12 weeks) expressed in mmHg

Outcome measures

Outcome measures
Measure	Patients Without Albuminuria Treated With Telmisartan n=1281 Participants	Patients With Albuminuria Treated With Telmisartan n=457 Participants
Mean Difference in Diastolic Blood Pressure	11.7 mmHg Standard Deviation 9.22	12.5 mmHg Standard Deviation 8.53

SECONDARY outcome

Timeframe: approximately 12 weeks (10 to 14 weeks) after baseline

Population: 1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)

The response in SBP after approximately 12 weeks of treatment including telmisartan defined as a fall in SBP (SBP (baseline) - SBP (12 weeks) ≥ 10 mmHg

Outcome measures

Outcome measures
Measure	Patients Without Albuminuria Treated With Telmisartan n=1281 Participants	Patients With Albuminuria Treated With Telmisartan n=457 Participants
Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders)	87.7 Percentage of patients 0.92	88.6 Percentage of patients 1.49

SECONDARY outcome

Timeframe: baseline to the end of study period

Population: 1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)

Percentage of patients with any adverse events during the study period, related or not to investigational drug

Outcome measures

Outcome measures
Measure	Patients Without Albuminuria Treated With Telmisartan n=1284 Participants	Patients With Albuminuria Treated With Telmisartan n=457 Participants
Percentage of Patients Presenting an Adverse Event (AE)	0.7 percentage of patients	0.44 percentage of patients

SECONDARY outcome

Timeframe: Approximately 12 weeks (10 to 14 weeks) after baseline

Population: All patients with albuminuria at initial visit and for which information on albuminuria was known at visit 2, 12 weeks after the initial visit.

Percentage of patients shifting from with (positive) albuminuria at baseline to without (negative) albuminuria after approximately 12 weeks

Outcome measures

Outcome measures
Measure	Patients Without Albuminuria Treated With Telmisartan n=331 Participants	Patients With Albuminuria Treated With Telmisartan
Percentage of Patients With Positive to Negative Shift in Albuminuria	53.8 Percentage of patients Interval 48.4 to 59.2	—

Adverse Events

Patients Without Albuminuria Treated With Telmisartan

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients With Albuminuria Treated With Telmisartan

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients Without Albuminuria Treated With Telmisartan n=2027 participants at risk	Patients With Albuminuria Treated With Telmisartan n=684 participants at risk	n=163 participants at risk patients without baseline albuminuria data
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian metastases	0.00% 0/2027 • From signing of informed consent through the end of the study 2874 participants at risk= patients without major protocol violation	0.15% 1/684 • From signing of informed consent through the end of the study 2874 participants at risk= patients without major protocol violation	0.00% 0/163 • From signing of informed consent through the end of the study 2874 participants at risk= patients without major protocol violation
Cardiac disorders Myocardial infarct	0.05% 1/2027 • From signing of informed consent through the end of the study 2874 participants at risk= patients without major protocol violation	0.00% 0/684 • From signing of informed consent through the end of the study 2874 participants at risk= patients without major protocol violation	0.00% 0/163 • From signing of informed consent through the end of the study 2874 participants at risk= patients without major protocol violation

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Pharmaceuticals

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER