NCT00877929CompletedPhase 3
An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 + Amlodipine 10mg Versus Amlodipine 10 mg Monotherapy as First Line Therapy in Type 2 Diabetes Patients With Hypertension.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 706
- Locations
- 65
- Primary Endpoint
- Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8
Study Overview
Brief Summary
To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Telmisartan 80 / Amlodipine 10
Experimental
Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination
Intervention: Telmisartan 80 (Drug)
Telmisartan 80 / Amlodipine 10
Experimental
Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination
Intervention: Amlodipine 10 (Drug)
Amlodipine 10
Active Comparator
Amlodipine 5 for two weeks, then forced titration to Amlodipine 10
Intervention: Amlodipine 10 (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8
Time Frame: 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 Outcomes
- Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6(Baseline, week 6)
- Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4(Baseline, week 4)
- Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2(Baseline, week 2)
- Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1(Baseline, week 1)
- Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks(Baseline, week 8)
- BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks(Baseline, week 6)
- BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks(Baseline, week 4)
- BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks(Baseline, week 2)
- BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week(Baseline, week 1)
- BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks(Baseline, week 8)
- BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks(Baseline, week 6)
- BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks(Baseline, week 4)
- BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks(Baseline, week 2)
- BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week(Baseline, week 1)
- Systolic Blood Pressure (SBP) Control 140 at Eight Weeks(Baseline, week 8)
- SBP Control 140 at Six Weeks(Baseline, week 6)
- SBP Control 140 at Four Weeks(Baseline, week 4)
- SBP Control 140 at Two Weeks(Baseline, week 2)
- SBP Control 140 at One Week(Baseline, week 1)
- SBP Control 130 at Eight Weeks(Baseline, week 8)
- SBP Control 130 at Six Weeks(Baseline, week 6)
- SBP Control 130 at Four Weeks(Baseline, week 4)
- SBP Control 130 at Two Weeks(Baseline, week 2)
- SBP Control 130 at One Week(Baseline, week 1)
- SBP Response 140 at Eight Weeks(Baseline, week 8)
- SBP Response 140 at Six Weeks(Baseline, week 6)
- SBP Response 140 at Four Weeks(Baseline, week 4)
- SBP Response 140 at Two Weeks(Baseline, week 2)
- SBP Response 140 at One Week(Baseline, week 1)
- SBP Response 130 at Eight Weeks(Baseline, week 8)
- SBP Response 130 at Six Weeks(Baseline, week 6)
- SBP Response 130 at Four Weeks(Baseline, week 4)
- SBP Response 130 at Two Weeks(Baseline, week 2)
- SBP Response 130 at One Week(Baseline, week 1)
- DBP Response at Eight Weeks(Week 8)
- DBP Response at Six Weeks(week 6)
- DBP Response at Week Four(Week 4)
- DBP Response at Week Two(Week 2)
- DBP Response at Week One(Week 1)
- Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)(8 weeks)
Investigators
Study Sites (65)
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