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)
502.550.01007 Boehringer Ingelheim Investigational Site
🇺🇸Greensboro, North Carolina, United States
502.550.86002 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
502.550.86007 Boehringer Ingelheim Investigational Site
🇨🇳Tianjin, China
502.550.86010 Boehringer Ingelheim Investigational Site
🇨🇳Zhengzhou, China
502.550.35903 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
502.550.35905 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
502.550.40002 Boehringer Ingelheim Investigational Site
🇷🇴Baia Mare Maramures, Romania
502.550.40012 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
502.550.07007 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
502.550.07010 Boehringer Ingelheim Investigational Site
🇷🇺St.Petersburg, Russian Federation
502.550.07004 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
502.550.07006 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
502.550.40006 Boehringer Ingelheim Investigational Site
🇷🇴Iasi, Romania
502.550.35902 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
502.550.35908 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
502.550.35906 Boehringer Ingelheim Investigational Site
🇧🇬Stara Zagora, Bulgaria
502.550.99504 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
502.550.40001 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
502.550.40011 Boehringer Ingelheim Investigational Site
🇷🇴Cluj Napoca, Romania
502.550.07009 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
502.550.07005 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
502.550.35901 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
502.550.35911 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
502.550.99501 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
502.550.99502 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
502.550.99505 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
502.550.99506 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
502.550.40010 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
502.550.01011 Boehringer Ingelheim Investigational Site
🇺🇸New Iberia, Louisiana, United States
502.550.07003 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
502.550.35910 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
502.550.99503 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
502.550.99507 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
502.550.40009 Boehringer Ingelheim Investigational Site
🇷🇴Cluj Napoca, Romania
502.550.40004 Boehringer Ingelheim Investigational Site
🇷🇴Oradea, Romania
502.550.01009 Boehringer Ingelheim Investigational Site
🇺🇸New Orleans, Louisiana, United States
502.550.01018 Boehringer Ingelheim Investigational Site
🇺🇸Olive Branch, Mississippi, United States
502.550.07002 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
502.550.40008 Boehringer Ingelheim Investigational Site
🇷🇴Tg. Mures, Romania
502.550.3303A Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
502.550.3303D Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
502.550.3304F Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
502.550.3303C Boehringer Ingelheim Investigational Site
🇫🇷Roquevaire, France
502.550.01019 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States
502.550.01006 Boehringer Ingelheim Investigational Site
🇺🇸St. Louis, Missouri, United States
502.550.01015 Boehringer Ingelheim Investigational Site
🇺🇸Lomita, California, United States
502.550.01008 Boehringer Ingelheim Investigational Site
🇺🇸Athens, Alabama, United States
502.550.01014 Boehringer Ingelheim Investigational Site
🇺🇸Fort Lauderdale, Florida, United States
502.550.01017 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
502.550.86004 Boehringer Ingelheim Investigational Site
🇨🇳Changsha, China
502.550.35904 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
502.550.01012 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
502.550.86009 Boehringer Ingelheim Investigational Site
🇨🇳Shenyang, China
502.550.3302D Boehringer Ingelheim Investigational Site
🇫🇷Aigrefeuille S/Maine, France
502.550.35909 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
502.550.3305I Boehringer Ingelheim Investigational Site
🇫🇷Aix-en-Provence, France
502.550.3301K Boehringer Ingelheim Investigational Site
🇫🇷Cholet, France
502.550.01001 Boehringer Ingelheim Investigational Site
🇺🇸Cleveland, Ohio, United States
502.550.01020 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
502.550.86003 Boehringer Ingelheim Investigational Site
🇨🇳Guangzhou, Guangdong Province, China
502.550.86008 Boehringer Ingelheim Investigational Site
🇨🇳QingDao, China
502.550.86001 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
502.550.3305G Boehringer Ingelheim Investigational Site
🇫🇷Aubagne, France
502.550.3301H Boehringer Ingelheim Investigational Site
🇫🇷Briollay, France
502.550.3302I Boehringer Ingelheim Investigational Site
🇫🇷Corsept, France
502.550.3302C Boehringer Ingelheim Investigational Site
🇫🇷Donges, France
502.550.3302B Boehringer Ingelheim Investigational Site
🇫🇷La Montagne, France
502.550.3306A Boehringer Ingelheim Investigational Site
🇫🇷Louvigné de Bais, France
502.550.3304A Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
502.550.3304D Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
502.550.99508 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
502.550.82012 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
502.550.3301F Boehringer Ingelheim Investigational Site
🇫🇷Segre, France
502.550.3302G Boehringer Ingelheim Investigational Site
🇫🇷St Aubin les Châteaux, France
502.550.3306F Boehringer Ingelheim Investigational Site
🇫🇷St Jouan des Guerets, France
502.550.3307A Boehringer Ingelheim Investigational Site
🇫🇷Thouars, France
502.550.3301J Boehringer Ingelheim Investigational Site
🇫🇷Vihiers, France
502.550.82008 Boehringer Ingelheim Investigational Site
🇰🇷Cheonan, Korea, Republic of
502.550.82006 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
502.550.40003 Boehringer Ingelheim Investigational Site
🇷🇴Braila, Romania
502.550.07001 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
502.550.01003 Boehringer Ingelheim Investigational Site
🇺🇸Colorado Springs, Colorado, United States
502.550.82002 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
502.550.82013 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
502.550.01002 Boehringer Ingelheim Investigational Site
🇺🇸Louisville, Kentucky, United States
502.550.01005 Boehringer Ingelheim Investigational Site
🇺🇸Cincinnati, Ohio, United States
502.550.01016 Boehringer Ingelheim Investigational Site
🇺🇸Charlotte, North Carolina, United States
502.550.01004 Boehringer Ingelheim Investigational Site
🇺🇸Arlington, Virginia, United States
502.550.3303F Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
502.550.3304J Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
502.550.3305A Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
502.550.3301A Boehringer Ingelheim Investigational Site
🇫🇷Murs Erigne, France
502.550.3301I Boehringer Ingelheim Investigational Site
🇫🇷Murs-Erigne, France
502.550.3301E Boehringer Ingelheim Investigational Site
🇫🇷Parcay-les-Pins, France
502.550.3302A Boehringer Ingelheim Investigational Site
🇫🇷Nantes, France
502.550.3302E Boehringer Ingelheim Investigational Site
🇫🇷Nantes, France
502.550.82009 Boehringer Ingelheim Investigational Site
🇰🇷Daegu, Korea, Republic of
502.550.82001 Boehringer Ingelheim Investigational Site
🇰🇷Goyang, Korea, Republic of
502.550.82003 Boehringer Ingelheim Investigational Site
🇰🇷Gwangju, Korea, Republic of
502.550.82005 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
502.550.82011 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
502.550.82007 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
502.550.82010 Boehringer Ingelheim Investigational Site
🇰🇷Wonju, Korea, Republic of
502.550.82004 Boehringer Ingelheim Investigational Site
🇰🇷Suwon, Korea, Republic of
502.550.40005 Boehringer Ingelheim Investigational Site
🇷🇴Sibiu, Romania
502.550.07008 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation