Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus
- Registration Number
- NCT00877929
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 706
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telmisartan 80 / Amlodipine 10 Telmisartan 80 Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination Amlodipine 10 Amlodipine 10 Amlodipine 5 for two weeks, then forced titration to Amlodipine 10 Telmisartan 80 / Amlodipine 10 Amlodipine 10 Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination
- Primary Outcome Measures
Name Time Method Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8 Baseline, week 8 Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6 Baseline, week 6 Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4 Baseline, week 4 Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2 Baseline, week 2 Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1 Baseline, week 1 Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks Baseline, week 8 Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks Baseline, week 6 Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks Baseline, week 4 Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks Baseline, week 2 Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week Baseline, week 1 Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks Baseline, week 8 Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks Baseline, week 6 Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks Baseline, week 4 Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks Baseline, week 2 Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week Baseline, week 1 Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
Systolic Blood Pressure (SBP) Control 140 at Eight Weeks Baseline, week 8 Mean seated SBP \< 140 mmHg
SBP Control 140 at Six Weeks Baseline, week 6 Mean seated SBP \< 140 mmHg
SBP Control 140 at Four Weeks Baseline, week 4 Mean seated SBP \< 140 mmHg
SBP Control 140 at Two Weeks Baseline, week 2 Mean seated SBP \< 140 mmHg
SBP Control 140 at One Week Baseline, week 1 Mean seated SBP \< 140 mmHg
SBP Control 130 at Eight Weeks Baseline, week 8 Mean seated SBP \< 130 mmHg
SBP Control 130 at Six Weeks Baseline, week 6 Mean seated SBP \< 130 mmHg
SBP Control 130 at Four Weeks Baseline, week 4 Mean seated SBP \< 130 mmHg
SBP Control 130 at Two Weeks Baseline, week 2 Mean seated SBP \< 130 mmHg
SBP Control 130 at One Week Baseline, week 1 Mean seated SBP \< 130 mmHg
SBP Response 140 at Eight Weeks Baseline, week 8 SBP \< 140 mmHg or a reduction \>=10 mmHg
SBP Response 140 at Six Weeks Baseline, week 6 SBP \<140 mmHg or a reduction \>=10 mmHg
SBP Response 140 at Four Weeks Baseline, week 4 SBP \<140 mmHg or a reduction \>=10 mmHg
SBP Response 140 at Two Weeks Baseline, week 2 SBP \<140 mmHg or a reduction \>=10 mmHg
SBP Response 140 at One Week Baseline, week 1 SBP \<140 mmHg or a reduction \>=10 mmHg
SBP Response 130 at Eight Weeks Baseline, week 8 SBP \<130 mmHg or a reduction \>=10 mmHg
SBP Response 130 at Six Weeks Baseline, week 6 SBP \<130 mmHg or a reduction \>=10 mmHg
SBP Response 130 at Four Weeks Baseline, week 4 SBP \<130 mmHg or a reduction \>=10 mmHg
SBP Response 130 at Two Weeks Baseline, week 2 SBP \<130 mmHg or a reduction \>=10 mmHg
SBP Response 130 at One Week Baseline, week 1 SBP \<130 mmHg or a reduction \>=10 mmHg
DBP Response at Eight Weeks Week 8 Mean seated DBP\<80 mmHg or a reduction of \<=10 mmHg
DBP Response at Six Weeks week 6 Mean seated DBP\<80 mmHg or a reduction of \<=10 mmHg
DBP Response at Week Four Week 4 Mean seated DBP \<80 mmHg or a reduction of \>=10 mmHg
DBP Response at Week Two Week 2 Mean seated DBP \<80 mmHg or a reduction of \>=10 mmHg
DBP Response at Week One Week 1 Mean seated DBP \<80 mmHg or a reduction of \>=10 mmHg
Change From Baseline in Urine Albumin:Creatinine Ratio (UACR) 8 weeks Change from baseline in UACR (measured in spot urine) after eight weeks of treatment
Trial Locations
- Locations (65)
1235.21.907 Boehringer Ingelheim Investigational Site
🇺🇸Tustin, California, United States
1235.21.913 Boehringer Ingelheim Investigational Site
🇺🇸Fort Lauderdale, Florida, United States
1235.21.910 Boehringer Ingelheim Investigational Site
🇺🇸Hollywood, Florida, United States
1235.21.905 Boehringer Ingelheim Investigational Site
🇺🇸Tucker, Georgia, United States
1235.21.909 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1235.21.915 Boehringer Ingelheim Investigational Site
🇺🇸Hickory, North Carolina, United States
1235.21.202 Boehringer Ingelheim Investigational Site
🇰🇷Incheon, Korea, Republic of
1235.21.916 Boehringer Ingelheim Investigational Site
🇺🇸Olive Branch, Mississippi, United States
1235.21.107 Boehringer Ingelheim Investigational Site
🇦🇷Ramos MejÃa, Argentina
1235.21.912 Boehringer Ingelheim Investigational Site
🇺🇸Killeen, Texas, United States
1235.21.901 Boehringer Ingelheim Investigational Site
🇺🇸Long Beach, California, United States
1235.21.911 Boehringer Ingelheim Investigational Site
🇺🇸Ettrick, Virginia, United States
1235.21.904 Boehringer Ingelheim Investigational Site
🇺🇸Penndel, Pennsylvania, United States
1235.21.103 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
1235.21.302 Boehringer Ingelheim Investigational Site
🇲🇽Acapulco, Mexico
1235.21.801 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1235.21.802 Boehringer Ingelheim Investigational Site
🇸🇪Västerås, Sweden
1235.21.702 Boehringer Ingelheim Investigational Site
🇪🇸Castellón, Spain
1235.21.703 Boehringer Ingelheim Investigational Site
🇪🇸Sant Adrià del Besós, Spain
1235.21.27004 Boehringer Ingelheim Investigational Site
🇿🇦Durban, South Africa
1235.21.201 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1235.21.27003 Boehringer Ingelheim Investigational Site
🇿🇦Pretoria, South Africa
1235.21.204 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1235.21.27001 Boehringer Ingelheim Investigational Site
🇿🇦Lenasia, South Africa
1235.21.301 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1235.21.27002 Boehringer Ingelheim Investigational Site
🇿🇦Krugersdorp, South Africa
1235.21.404 Boehringer Ingelheim Investigational Site
🇳🇱Nijverdal, Netherlands
1235.21.101 Boehringer Ingelheim Investigational Site
🇦🇷Santa Fe, Argentina
1235.21.705 Boehringer Ingelheim Investigational Site
🇪🇸Centelles, Spain
1235.21.27007 Boehringer Ingelheim Investigational Site
🇿🇦Cape Town, South Africa
1235.21.505 Boehringer Ingelheim Investigational Site
🇸🇰Nitra, Slovakia
1235.21.405 Boehringer Ingelheim Investigational Site
🇳🇱Musselkanaal, Netherlands
1235.21.803 Boehringer Ingelheim Investigational Site
🇸🇪Helsingborg, Sweden
1235.21.706 Boehringer Ingelheim Investigational Site
🇪🇸Santa Coloma de Gramanet, Spain
1235.21.407 Boehringer Ingelheim Investigational Site
🇳🇱Voerendaal, Netherlands
1235.21.506 Boehringer Ingelheim Investigational Site
🇸🇰Nitra, Slovakia
1235.21.406 Boehringer Ingelheim Investigational Site
🇳🇱Den Haag, Netherlands
1235.21.704 Boehringer Ingelheim Investigational Site
🇪🇸Santa Coloma de Gramanet (Barcelona), Spain
1235.21.401 Boehringer Ingelheim Investigational Site
🇳🇱Hoogwoud, Netherlands
1235.21.403 Boehringer Ingelheim Investigational Site
🇳🇱Oude Pekela, Netherlands
1235.21.502 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
1235.21.503 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
1235.21.509 Boehringer Ingelheim Investigational Site
🇸🇰Martin, Slovakia
1235.21.205 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1235.21.105 Boehringer Ingelheim Investigational Site
🇦🇷Zárate, Argentina
1235.21.903 Boehringer Ingelheim Investigational Site
🇺🇸Pembroke Pines, Florida, United States
1235.21.908 Boehringer Ingelheim Investigational Site
🇺🇸Carrollton, Texas, United States
1235.21.102 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
1235.21.408 Boehringer Ingelheim Investigational Site
🇳🇱Beek en Donk, Netherlands
1235.21.305 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1235.21.203 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1235.21.409 Boehringer Ingelheim Investigational Site
🇳🇱Roelofarensveen, Netherlands
1235.21.501 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
1235.21.402 Boehringer Ingelheim Investigational Site
🇳🇱Wildervank, Netherlands
1235.21.507 Boehringer Ingelheim Investigational Site
🇸🇰Dunajska Streda, Slovakia
1235.21.27005 Boehringer Ingelheim Investigational Site
🇿🇦Cape Town, South Africa
1235.21.27006 Boehringer Ingelheim Investigational Site
🇿🇦Johannesburg, South Africa
1235.21.804 Boehringer Ingelheim Investigational Site
🇸🇪Lund, Sweden
1235.21.303 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1235.21.504 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
1235.21.304 Boehringer Ingelheim Investigational Site
🇲🇽Aguascalientes, Mexico
1235.21.508 Boehringer Ingelheim Investigational Site
🇸🇰Rimavska Sobota, Slovakia
1235.21.306 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1235.21.906 Boehringer Ingelheim Investigational Site
🇺🇸Winston-Salem, North Carolina, United States
1235.21.902 Boehringer Ingelheim Investigational Site
🇺🇸Oklahoma City, Oklahoma, United States