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Trial record 29 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

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

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ClinicalTrials.gov Identifier: NCT00909038
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : April 14, 2011
Last Update Posted : June 5, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Hypertension
Enrollment 2411
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg
Hide Arm/Group Description Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Period Title: Overall Study
Started 2411
Completed 1994
Not Completed 417
Reason Not Completed
Protocol Violation             187
Non-evaluable Subjects             230
Arm/Group Title Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg
Hide Arm/Group Description Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Overall Number of Baseline Participants 1994
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1994 participants
63.5  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1994 participants
Female
835
  41.9%
Male
1159
  58.1%
Hypertension treatments prescribed prior to initiation of treatment   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 1994 participants
Angiotensin II antagonist 71.8
Diuretic 64.3
Calcium channel blocker 23.3
Beta-blocker 20.5
[1]
Measure Description: Hypertension treatments prescribed prior to initiation of treatment with telmisartan 80mg in a FDC with HCTZ 25 mg
Conditions for prescribing 80 mg telmisartan in fixed combination with 25 mg HCTZ   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 1994 participants
Lack of efficacy 53.8
To decrease the number of treatment 33.1
[1]
Measure Description:

Conditions for prescribing 80 mg telmisartan in fixed combination with 25 mg HCTZ were ,

"Lack of efficacy of previous treatments" and "To decrease the number of treatment administration throughout the day"

Cardiovascular risk factors (including the existence of a metabolic syndrome)   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 1994 participants
Age (male>50 or female>60) 82.0
Smoking 23.9
Family History 28.9
Diabetes 54.3
LDL-Cholesterol ≥ 1.6 g/L 72.4
HDL-Cholesterol ≤ 0.4 g/L 20.5
[1]
Measure Description: Number of Patients used in the analysis for Cardiovascular risk factors (including the existence of a metabolic syndrome) were 322 Participants with existence of a metabolic syndrome
1.Primary Outcome
Title Rate of BP Control in Hypertensive Patients
Hide Description

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.

Time Frame Baseline to a minimum of 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg
Hide Arm/Group Description:
Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Overall Number of Participants Analyzed 1994
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
51.3
(49.0 to 53.5)
2.Secondary Outcome
Title Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population
Hide Description Mean SBP measured at the Study End
Time Frame baseline to a minimum of 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg
Hide Arm/Group Description:
Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Overall Number of Participants Analyzed 1994
Mean (Standard Deviation)
Unit of Measure: mm Hg
137.3  (9.6)
3.Secondary Outcome
Title Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population
Hide Description Mean DBP measured at the Study End
Time Frame baseline to a minimum of 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg
Hide Arm/Group Description:
Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Overall Number of Participants Analyzed 1994
Mean (Standard Deviation)
Unit of Measure: mm Hg
80.1  (7.2)
4.Secondary Outcome
Title Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk
Hide Description Mean SBP measured at the Study End
Time Frame baseline to a minimum of 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg
Hide Arm/Group Description:
Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Overall Number of Participants Analyzed 972
Mean (Standard Deviation)
Unit of Measure: mmHg
144.3  (7.9)
5.Secondary Outcome
Title Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk
Hide Description Mean DBP measured at the Study End
Time Frame baseline to a minimum of 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg
Hide Arm/Group Description:
Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Overall Number of Participants Analyzed 972
Mean (Standard Deviation)
Unit of Measure: mmHg
82.9  (7.2)
6.Secondary Outcome
Title Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007
Hide Description 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.
Time Frame Baseline to a minimum of 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set (PPS)
Arm/Group Title Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg
Hide Arm/Group Description:
Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
Overall Number of Participants Analyzed 661
Measure Type: Number
Unit of Measure: percentage of patients
Age >60 years 51.9
Diabetes 5.0
Renal Failure 3.8
History of TIA/CVA 3.9
Coronary Chronic Disease 8.3
Time Frame 6 months
Adverse Event Reporting Description Study duration between first included and last included patients.
 
Arm/Group Title Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg
Hide Arm/Group Description Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
All-Cause Mortality
Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg
Affected / at Risk (%)
Total   0/1994 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg
Affected / at Risk (%)
Total   0/1994 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00909038     History of Changes
Other Study ID Numbers: 502.574
First Submitted: May 26, 2009
First Posted: May 27, 2009
Results First Submitted: March 23, 2011
Results First Posted: April 14, 2011
Last Update Posted: June 5, 2014