8 Week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg+ Amlodipine 5 mg vs. Amlodipine 5mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy
Overview
- Phase
- Phase 3
- Intervention
- Telmisartan80mg+Amlodipine5mg
- Conditions
- Hypertension
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 324
- Locations
- 16
- Primary Endpoint
- Change From Baseline in DBP After 8 Weeks of Treatment
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Telmisartan80mg+Amlodipine5mg
combination therapy
Intervention: Telmisartan80mg+Amlodipine5mg
amlodipine 5 mg
Monotherapy
Intervention: amlodipine 5mg
amlodipine 5 mg
Monotherapy
Intervention: Telmisartan80mg+Amlodipine 5mg
Outcomes
Primary Outcomes
Change From Baseline in DBP After 8 Weeks of Treatment
Time Frame: Baseline and 8 weeks
Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients
Time Frame: Baseline and 8 weeks
Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.
Secondary Outcomes
- Change From Baseline in SBP After 8 Weeks of Treatment(Baseline and 8 weeks)
- DBP and SBP Control and Response After 8 Weeks of Treatment(Baseline and 8 weeks)
- Number of Patients in Blood Pressure Categories Over Time(8 weeks)
- Change From Baseline in DBP After 4 Weeks of Treatment(Baseline and 4 weeks)
- Change From Baseline in SBP After 4 Weeks of Treatment(Baseline and 4 weeks)
- DBP and SBP Control and Response After 4 Weeks of Treatment(Baseline and 4 weeks)
- Number of Patients in Blood Pressure Categories at 4 Weeks(4 weeks)
- Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.(From drug administration until end of treatment plus one day)