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)
1235.21.901 Boehringer Ingelheim Investigational Site
🇺🇸Long Beach, California, United States
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
1235.21.903 Boehringer Ingelheim Investigational Site
🇺🇸Pembroke Pines, Florida, United States
1235.21.905 Boehringer Ingelheim Investigational Site
🇺🇸Tucker, Georgia, United States
1235.21.916 Boehringer Ingelheim Investigational Site
🇺🇸Olive Branch, Mississippi, United States
1235.21.915 Boehringer Ingelheim Investigational Site
🇺🇸Hickory, North Carolina, United States
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
Scroll for more (55 remaining)1235.21.901 Boehringer Ingelheim Investigational Site🇺🇸Long Beach, California, United States