Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension
- Registration Number
- NCT00926289
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP\>=160 mmHg and Diastolic Blood Pressure(DBP)\>=100 mmHg).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 894
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telmisartan Telmisartan Telmisartan 80 mg Telmisartan/hydrochlorothiazide Telmisartan Telmisartan80mg/Hydrochlorothiazide25mg Telmisartan/hydrochlorothiazide Hydrochlorothiazide Telmisartan80mg/Hydrochlorothiazide25mg
- Primary Outcome Measures
Name Time Method Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 Baseline and Week 7 The SBP value at baseline was subtracted from the SBP value at Week 7.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Mean Seated Trough Cuff SBP to Week 5 Baseline and Week 5 The SBP value at baseline was subtracted from the SBP value at Week 5.
Change From Baseline in Mean Seated Trough Cuff SBP to Week 3 Baseline and Week 3 The SBP value at baseline was subtracted from the SBP value at Week 3.
Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7 Baseline and Week 7 The DBP value at baseline was subtracted from the DBP value at Week 7.
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7 Week 7 timepoint SBP control is defined as SBP \< 140 mmHg.
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5 Week 5 timepoint SBP control is defined as SBP \< 140 mmHg
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3 Week 3 timepoint SBP control is defined as SBP \< 140 mmHg
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7 Week 7 timepoint DBP control is defined as DBP\<90 mmHg
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5 Week 5 timepoint DBP control is defined as DBP\<90 mmHg
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3 Week 3 timepoint DBP control is defined as DBP\<90 mmHg
Number of Patients With Blood Pressure (BP) Control at Week 7 Week 7 timepoint BP control is defined as SBP\<140 mmHg and DBP \< 90 mmHg and is adjusted for baseline SBP
Number of Patients With BP Control at Week 7 Week 7 timepoint BP control is defined as SBP\<140 mmHg and DBP \< 90 mmHg and is adjusted for baseline DBP
Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7 Week 7 timepoint SBP response is defined as SBP\<140 mmHg or a reduction of \>= 15 mmHg
Number of Participants With DBP Response at Week 7 Week 7 timepoint DBP response is defined as DBP\<90 mmHg or a reduction of \>= 10 mmHg
BP Categories at Week 7 Week 7 timepoint BP categories comprise:
* BP optimal (SBP \<120 mmHg and DBP \<80 mmHg)
* BP normal (SBP \<130 mmHg and DBP \<85 mmHg but not 'optimal')
* BP high normal (SBP \<140 mmHg and DBP \<90 mmHg but not 'normal')
* Grade 1 hypertension (SBP \<160 mmHg and DBP \<100 mmHg but not 'high normal')
* Grade 2 hypertension (SBP \<180 mmHg and DBP \<110 mmHg but not 'Grade 1 hypertension')
* Grade 3 hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg)
Trial Locations
- Locations (106)
502.550.01008 Boehringer Ingelheim Investigational Site
🇺🇸Athens, Alabama, United States
502.550.01019 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States
502.550.01015 Boehringer Ingelheim Investigational Site
🇺🇸Lomita, California, United States
502.550.01003 Boehringer Ingelheim Investigational Site
🇺🇸Colorado Springs, Colorado, United States
502.550.01014 Boehringer Ingelheim Investigational Site
🇺🇸Fort Lauderdale, Florida, United States
502.550.01002 Boehringer Ingelheim Investigational Site
🇺🇸Louisville, Kentucky, United States
502.550.01011 Boehringer Ingelheim Investigational Site
🇺🇸New Iberia, Louisiana, United States
502.550.01009 Boehringer Ingelheim Investigational Site
🇺🇸New Orleans, Louisiana, United States
502.550.01018 Boehringer Ingelheim Investigational Site
🇺🇸Olive Branch, Mississippi, United States
502.550.01006 Boehringer Ingelheim Investigational Site
🇺🇸St. Louis, Missouri, United States
Scroll for more (96 remaining)502.550.01008 Boehringer Ingelheim Investigational Site🇺🇸Athens, Alabama, United States