Trial Outcomes & Findings for Telmisartan 80mg+Hydrochlorothiazide (HCTZ) 25 mg in Hypertension: an Observational Study (NCT NCT00909038)

Last Updated: 2014-06-05

Results Overview

Percentage of controlled Patients at the Study End. Control rate of hypertension in general practice and in cardiology defined as systolic blood pressure (SBP) and diastolic blood pressure (DBP) \<140/90 mmHg for unselected hypertensive patients and SBP and DBP \<130/80 mmHg for hypertensive patients at high cardiovascular risk (patients with diabetes and patients with impaired renal function) as defined in the recommendations of the French National Health Authority (HAS) 2005 guidelines.

Recruitment status

COMPLETED

Target enrollment

2411 participants

Primary outcome timeframe

Baseline to a minimum of 8 weeks of treatment

Results posted on

2014-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Overall Study STARTED	2411
Overall Study COMPLETED	1994
Overall Study NOT COMPLETED	417

Reasons for withdrawal

Reasons for withdrawal
Measure	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Overall Study Protocol Violation	187
Overall Study Non-evaluable Subjects	230

Baseline Characteristics

Telmisartan 80mg+Hydrochlorothiazide (HCTZ) 25 mg in Hypertension: an Observational Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg n=1994 Participants Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Age, Continuous	63.5 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	835 Participants n=5 Participants
Sex: Female, Male Male	1159 Participants n=5 Participants
Hypertension treatments prescribed prior to initiation of treatment Angiotensin II antagonist	71.8 Percentage of participants n=5 Participants
Hypertension treatments prescribed prior to initiation of treatment Diuretic	64.3 Percentage of participants n=5 Participants
Hypertension treatments prescribed prior to initiation of treatment Calcium channel blocker	23.3 Percentage of participants n=5 Participants
Hypertension treatments prescribed prior to initiation of treatment Beta-blocker	20.5 Percentage of participants n=5 Participants
Conditions for prescribing 80 mg telmisartan in fixed combination with 25 mg HCTZ Lack of efficacy	53.8 Percentage of participants n=5 Participants
Conditions for prescribing 80 mg telmisartan in fixed combination with 25 mg HCTZ To decrease the number of treatment	33.1 Percentage of participants n=5 Participants
Cardiovascular risk factors (including the existence of a metabolic syndrome) Age (male>50 or female>60)	82.0 Percentage of participants n=5 Participants
Cardiovascular risk factors (including the existence of a metabolic syndrome) Smoking	23.9 Percentage of participants n=5 Participants
Cardiovascular risk factors (including the existence of a metabolic syndrome) Family History	28.9 Percentage of participants n=5 Participants
Cardiovascular risk factors (including the existence of a metabolic syndrome) Diabetes	54.3 Percentage of participants n=5 Participants
Cardiovascular risk factors (including the existence of a metabolic syndrome) LDL-Cholesterol ≥ 1.6 g/L	72.4 Percentage of participants n=5 Participants
Cardiovascular risk factors (including the existence of a metabolic syndrome) HDL-Cholesterol ≤ 0.4 g/L	20.5 Percentage of participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to a minimum of 8 weeks of treatment

Population: Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.

Outcome measures

Outcome measures
Measure	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg n=1994 Participants Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Rate of BP Control in Hypertensive Patients	51.3 Percentage of Participants Interval 49.0 to 53.5

SECONDARY outcome

Timeframe: baseline to a minimum of 8 weeks of treatment

Mean SBP measured at the Study End

Outcome measures

Outcome measures
Measure	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg n=1994 Participants Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population	137.3 mm Hg Standard Deviation 9.6

SECONDARY outcome

Timeframe: baseline to a minimum of 8 weeks of treatment

Mean DBP measured at the Study End

Outcome measures

Outcome measures
Measure	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg n=1994 Participants Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population	80.1 mm Hg Standard Deviation 7.2

SECONDARY outcome

Timeframe: baseline to a minimum of 8 weeks of treatment

Mean SBP measured at the Study End

Outcome measures

Outcome measures
Measure	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg n=972 Participants Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk	144.3 mmHg Standard Deviation 7.9

SECONDARY outcome

Timeframe: baseline to a minimum of 8 weeks of treatment

Mean DBP measured at the Study End

Outcome measures

Outcome measures
Measure	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg n=972 Participants Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk	82.9 mmHg Standard Deviation 7.2

SECONDARY outcome

Timeframe: Baseline to a minimum of 8 weeks of treatment

Population: Per protocol set (PPS)

The proportion of patients with blood pressure (BP) control, per risk factor. High risk factors determined according to the recommendations of the ESH/ESC 2007.

Outcome measures

Outcome measures
Measure	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg n=661 Participants Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007 Age >60 years	51.9 percentage of patients Interval 99.4 to 100.0
Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007 Diabetes	5.0 percentage of patients Interval 18.3 to 24.7
Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007 Renal Failure	3.8 percentage of patients
Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007 History of TIA/CVA	3.9 percentage of patients
Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007 Coronary Chronic Disease	8.3 percentage of patients

Adverse Events

Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

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