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
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Trial Locations
- Locations (137)
1235.20.525 Boehringer Ingelheim Investigational Site
🇺🇸Buena Park, California, United States
1235.20.503 Boehringer Ingelheim Investigational Site
🇺🇸Long Beach, California, United States
1235.20.507 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
1235.20.521 Boehringer Ingelheim Investigational Site
🇺🇸Westlake Village, California, United States
1235.20.508 Boehringer Ingelheim Investigational Site
🇺🇸DeLand, Florida, United States
1235.20.506 Boehringer Ingelheim Investigational Site
🇺🇸Hialeah, Florida, United States
1235.20.519 Boehringer Ingelheim Investigational Site
🇺🇸Pembroke Pines, Florida, United States
1235.20.523 Boehringer Ingelheim Investigational Site
🇺🇸Port Orange, Florida, United States
Scroll for more (127 remaining)1235.20.525 Boehringer Ingelheim Investigational Site🇺🇸Buena Park, California, United States