Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00860262
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure \[SBP\] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 858
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description amlodipine amlodipine telmisartan and amlodipine used in combination vs amlodipine or telmisartan telmisartan and amlodipine telmisartan and amlodipine telmisartan and amlodipine used in combination vs amlodipine or telmisartan telmisartan telmisartan telmisartan and amlodipine used in combination vs amlodipine or telmisartan
- Primary Outcome Measures
Name Time Method Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 baseline and week 8 Overall mean reduction from a common mean baseline in SBP
- Secondary Outcome Measures
Name Time Method Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 baseline and week 1 Overall mean reduction from a common mean baseline in SBP
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 baseline and week 6 Overall mean reduction from a common mean baseline in SBP
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 baseline and week 4 Overall mean reduction from a common mean baseline in SBP
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 baseline and week 2 Overall mean reduction from a common mean baseline in SBP
Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 baseline and week 8 Overall mean reduction from a common mean baseline in DBP
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 baseline and week 6 Overall mean reduction from a common mean baseline in DBP
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 baseline and week 4 Overall mean reduction from a common mean baseline in DBP
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 baseline and week 2 Overall mean reduction from a common mean baseline in DBP
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 baseline and week 1 Overall mean reduction from a common mean baseline in DBP
Patients Achieving Diastolic Blood Pressure Control at Week 1 week 1 Diastolic Blood Pressure Control is defined as achieving DBP \< 90mmHg
Patients Achieving Diastolic Blood Pressure Control at Week 2 week 2 DBP \< 90 mmHg
Patients Achieving Blood Pressure Control at Week 1 week 1 Blood Pressure Control is defined as achieving SBP\< 140 mmHg and DBP \< 90mmHg
Patients Achieving Blood Pressure Control at Week 2 week 2 SBP \< 140 mmHg and DBP \< 90 mmHg
Patients Achieving Diastolic Blood Pressure Response at Week 1 baseline, week 1 Diastolic Blood Pressure Response is defined as achieving DBP \< 90 mmHg or a reduction of \>= 10 mmHg
Patients Achieving Diastolic Blood Pressure Response at Week 2 baseline, week 2 DBP \< 90 mmHg or reduction of \>= 10 mmHg
Patients Achieving Systolic Blood Pressure Response at Week 1 baseline, week 1 Systolic Blood Pressure Response Control is defined as achieving SBP \< 140 mmHg or a reduction of \>= 15 mmHg
Patients Achieving Systolic Blood Pressure Response at Week 2 baseline, week 2 SBP \< 140 mmHg or reduction of \>= 15 mmHg
Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 week 1 Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 week 2 Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Patients Achieving Diastolic Blood Pressure Control at Week 4 week 4 DBP \< 90 mmHg
Patients Achieving Diastolic Blood Pressure Control at Week 6 week 6 DBP \< 90 mmHg
Patients Achieving Diastolic Blood Pressure Control at Week 8 week 8 DBP \< 90 mmHg
Patients Achieving Blood Pressure Control at Week 4 week 4 SBP \< 140 mmHg and DBP \< 90 mmHg
Patients Achieving Blood Pressure Control at Week 6 week 6 SBP \< 140 mmHg and DBP \< 90 mmHg
Patients Achieving Blood Pressure Control at Week 8 week 8 SBP \< 140 mmHg and DBP \< 90 mmHg
Patients Achieving Diastolic Blood Pressure Response at Week 4 baseline, week 4 DBP \< 90 mmHg or reduction of \>= 10 mmHg
Patients Achieving Diastolic Blood Pressure Response at Week 6 baseline, week 6 DBP \< 90 mmHg or reduction of \>= 10 mmHg
Patients Achieving Diastolic Blood Pressure Response at Week 8 baseline, week 8 DBP \< 90 mmHg or reduction of \>= 10 mmHg
Patients Achieving Systolic Blood Pressure Response at Week 4 baseline, week 4 SBP \< 140 mmHg or reduction of \>= 15 mmHg
Patients Achieving Systolic Blood Pressure Response at Week 6 baseline, week 6 SBP \< 140 mmHg or reduction of \>= 15 mmHg
Patients Achieving Systolic Blood Pressure Response at Week 8 baseline, week 8 SBP \< 140 mmHg or reduction of \>= 15 mmHg
Patients Achieving Normal Blood Pressure Response at Week 4 week 4 Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Patients Achieving Normal Blood Pressure Response at Week 6 week 6 Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Patients Achieving Normal Blood Pressure Response at Week 8 week 8 Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Trial Locations
- Locations (137)
1235.20.008 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.20.152 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1235.20.254 Boehringer Ingelheim Investigational Site
🇷🇴Iasi, Romania
1235.20.251 Boehringer Ingelheim Investigational Site
🇷🇴Targu-Mures, Romania
1235.20.159 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1235.20.459 Boehringer Ingelheim Investigational Site
🇺🇦Odessa, Ukraine
1235.20.510 Boehringer Ingelheim Investigational Site
🇺🇸Las Vegas, Nevada, United States
1235.20.520 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1235.20.513 Boehringer Ingelheim Investigational Site
🇺🇸Tipton, Pennsylvania, United States
1235.20.521 Boehringer Ingelheim Investigational Site
🇺🇸Westlake Village, California, United States
1235.20.511 Boehringer Ingelheim Investigational Site
🇺🇸Kettering, Ohio, United States
1235.20.530 Boehringer Ingelheim Investigational Site
🇺🇸Killeen, Texas, United States
1235.20.001 Boehringer Ingelheim Investigational Site
🇧🇬Bourgas, Bulgaria
1235.20.526 Boehringer Ingelheim Investigational Site
🇺🇸Erie, Pennsylvania, United States
1235.20.522 Boehringer Ingelheim Investigational Site
🇺🇸Carrollton, Texas, United States
1235.20.535 Boehringer Ingelheim Investigational Site
🇺🇸Draper, Utah, United States
1235.20.533 Boehringer Ingelheim Investigational Site
🇺🇸Magna, Utah, United States
1235.20.515 Boehringer Ingelheim Investigational Site
🇺🇸Tulsa, Oklahoma, United States
1235.20.534 Boehringer Ingelheim Investigational Site
🇺🇸Medford, Oregon, United States
1235.20.108B Boehringer Ingelheim Investigational Site
🇫🇷Labarthe sur Leze, France
1235.20.101D Boehringer Ingelheim Investigational Site
🇫🇷Chambery, France
1235.20.108C Boehringer Ingelheim Investigational Site
🇫🇷Cugnaux, France
1235.20.101A Boehringer Ingelheim Investigational Site
🇫🇷Albens, France
1235.20.103C Boehringer Ingelheim Investigational Site
🇫🇷Beziers, France
1235.20.108F Boehringer Ingelheim Investigational Site
🇫🇷Fenouillet, France
1235.20.106A Boehringer Ingelheim Investigational Site
🇫🇷Bourg des cptes, France
1235.20.102F Boehringer Ingelheim Investigational Site
🇫🇷Arles, France
1235.20.103F Boehringer Ingelheim Investigational Site
🇫🇷Beziers, France
1235.20.102C Boehringer Ingelheim Investigational Site
🇫🇷Gemenos, France
1235.20.108E Boehringer Ingelheim Investigational Site
🇫🇷Carbonne, France
1235.20.102E Boehringer Ingelheim Investigational Site
🇫🇷Marseille, France
1235.20.109F Boehringer Ingelheim Investigational Site
🇫🇷Saint Aulaire, France
1235.20.519 Boehringer Ingelheim Investigational Site
🇺🇸Pembroke Pines, Florida, United States
1235.20.507 Boehringer Ingelheim Investigational Site
🇺🇸Long Beach, California, United States
1235.20.525 Boehringer Ingelheim Investigational Site
🇺🇸Buena Park, California, United States
1235.20.503 Boehringer Ingelheim Investigational Site
🇺🇸Long Beach, California, United States
1235.20.529 Boehringer Ingelheim Investigational Site
🇺🇸Roseville, California, United States
1235.20.518 Boehringer Ingelheim Investigational Site
🇺🇸Tustin, California, United States
1235.20.508 Boehringer Ingelheim Investigational Site
🇺🇸DeLand, Florida, United States
1235.20.528 Boehringer Ingelheim Investigational Site
🇺🇸Blue Ridge, Georgia, United States
1235.20.506 Boehringer Ingelheim Investigational Site
🇺🇸Hialeah, Florida, United States
1235.20.523 Boehringer Ingelheim Investigational Site
🇺🇸Port Orange, Florida, United States
1235.20.527 Boehringer Ingelheim Investigational Site
🇺🇸Bay City, Michigan, United States
1235.20.516 Boehringer Ingelheim Investigational Site
🇺🇸North Dartmouth, Massachusetts, United States
1235.20.517 Boehringer Ingelheim Investigational Site
🇺🇸Providence, Rhode Island, United States
1235.20.505 Boehringer Ingelheim Investigational Site
🇺🇸Saratoga Springs, Utah, United States
1235.20.537 Boehringer Ingelheim Investigational Site
🇺🇸Tacoma, Washington, United States
1235.20.053 Boehringer Ingelheim Investigational Site
🇨🇿Praha 5, Czech Republic
1235.20.059 Boehringer Ingelheim Investigational Site
🇨🇿Cesky Krumlov, Czech Republic
1235.20.057 Boehringer Ingelheim Investigational Site
🇨🇿Strakonice, Czech Republic
1235.20.055 Boehringer Ingelheim Investigational Site
🇨🇿Slany, Czech Republic
1235.20.103A Boehringer Ingelheim Investigational Site
🇫🇷Beziers, France
1235.20.103E Boehringer Ingelheim Investigational Site
🇫🇷Cournonterral, France
1235.20.109B Boehringer Ingelheim Investigational Site
🇫🇷Brive, France
1235.20.106D Boehringer Ingelheim Investigational Site
🇫🇷Etrelles, France
1235.20.101C Boehringer Ingelheim Investigational Site
🇫🇷Gresy Sur Aix, France
1235.20.102A Boehringer Ingelheim Investigational Site
🇫🇷Gemenos, France
1235.20.108A Boehringer Ingelheim Investigational Site
🇫🇷Labarthe Sur Leze, France
1235.20.106F Boehringer Ingelheim Investigational Site
🇫🇷Louvigne De bais, France
1235.20.107A Boehringer Ingelheim Investigational Site
🇫🇷Ortez, France
1235.20.106B Boehringer Ingelheim Investigational Site
🇫🇷Mordelles, France
1235.20.107G Boehringer Ingelheim Investigational Site
🇫🇷Orthez, France
1235.20.107B Boehringer Ingelheim Investigational Site
🇫🇷Orthez, France
1235.20.107E Boehringer Ingelheim Investigational Site
🇫🇷Orthez, France
1235.20.109A Boehringer Ingelheim Investigational Site
🇫🇷Rosiers d'Egletons, France
1235.20.104A Boehringer Ingelheim Investigational Site
🇫🇷Saint Etienne, France
1235.20.107F Boehringer Ingelheim Investigational Site
🇫🇷Salies de Bearn, France
1235.20.104D Boehringer Ingelheim Investigational Site
🇫🇷Saint Etienne, France
1235.20.105D Boehringer Ingelheim Investigational Site
🇫🇷Toulon, France
1235.20.105A Boehringer Ingelheim Investigational Site
🇫🇷Toulon, France
1235.20.161 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1235.20.158 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1235.20.153 Boehringer Ingelheim Investigational Site
🇭🇺Gyongyos, Hungary
1235.20.154 Boehringer Ingelheim Investigational Site
🇭🇺Miskolc, Hungary
1235.20.157 Boehringer Ingelheim Investigational Site
🇭🇺Miskolc, Hungary
1235.20.155 Boehringer Ingelheim Investigational Site
🇭🇺Mosonmagyarovar, Hungary
1235.20.207 Boehringer Ingelheim Investigational Site
🇰🇷Busan, Korea, Republic of
1235.20.205 Boehringer Ingelheim Investigational Site
🇰🇷Koyang, Korea, Republic of
1235.20.201 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1235.20.206 Boehringer Ingelheim Investigational Site
🇰🇷Chunan, Korea, Republic of
1235.20.203 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1235.20.252 Boehringer Ingelheim Investigational Site
🇷🇴Braila, Romania
1235.20.202 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1235.20.204 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1235.20.259 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1235.20.262 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1235.20.301 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.20.302 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.20.304 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.20.303 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.20.305 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1235.20.307 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1235.20.310 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.20.306 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1235.20.308 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1235.20.311 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1235.20.309 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1235.20.354 Boehringer Ingelheim Investigational Site
🇸🇰Rimavska Sobota, Slovakia
1235.20.353 Boehringer Ingelheim Investigational Site
🇸🇰Kosice, Slovakia
1235.20.355 Boehringer Ingelheim Investigational Site
🇸🇰Galanta, Slovakia
1235.20.351 Boehringer Ingelheim Investigational Site
🇸🇰Vrable, Slovakia
1235.20.408 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1235.20.406 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1235.20.402 Boehringer Ingelheim Investigational Site
🇪🇸Granada, Spain
1235.20.403 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1235.20.451 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1235.20.458 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1235.20.460 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1235.20.456 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.20.461 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.20.454 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.20.455 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.20.453 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.20.452 Boehringer Ingelheim Investigational Site
🇺🇦Lvov, Ukraine
1235.20.409 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1235.20.005 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.20.004 Boehringer Ingelheim Investigational Site
🇧🇬Stara Zagora, Bulgaria
1235.20.003 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.20.058 Boehringer Ingelheim Investigational Site
🇨🇿Tabor, Czech Republic
1235.20.253 Boehringer Ingelheim Investigational Site
🇷🇴Timisoara, Romania
1235.20.356 Boehringer Ingelheim Investigational Site
🇸🇰Trnava, Slovakia
1235.20.457 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.20.002 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.20.009 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.20.052 Boehringer Ingelheim Investigational Site
🇨🇿Benatky nad Jizerou, Czech Republic
1235.20.051 Boehringer Ingelheim Investigational Site
🇨🇿Plzen, Czech Republic
1235.20.054 Boehringer Ingelheim Investigational Site
🇨🇿Pribram, Czech Republic
1235.20.261 Boehringer Ingelheim Investigational Site
🇷🇴Oradea, Romania
1235.20.260 Boehringer Ingelheim Investigational Site
🇷🇴Tg. Mures, Romania
1235.20.352 Boehringer Ingelheim Investigational Site
🇸🇰Povazska Bystrica, Slovakia
1235.20.006 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.20.007 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.20.256 Boehringer Ingelheim Investigational Site
🇷🇴Sibiu, Romania
1235.20.501 Boehringer Ingelheim Investigational Site
🇺🇸Madison, Wisconsin, United States
1235.20.512 Boehringer Ingelheim Investigational Site
🇺🇸Albuquerque, New Mexico, United States
1235.20.509 Boehringer Ingelheim Investigational Site
🇺🇸Bronx, New York, United States
1235.20.156 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary