An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 259
- Locations
- 7
- Primary Endpoint
- Percentage of Participants Who Experienced Adverse Events
Study Overview
Brief Summary
To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy
Study Design
- Study Type
- Interventional
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with essential hypertension
Exclusion Criteria
- •Patients whose SBP >=180 mmHg or DBP >=110 mmHg at the end of treatment visit of the double-blind treatment period in the "non-responder trials"
- •Patients who have met any of the exclusion criteria defined in the "non-responder trials"
Outcomes
Primary Outcomes
Percentage of Participants Who Experienced Adverse Events
Time Frame: 52 weeks
An adverse event is defined as any untoward medical occurrence
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Time Frame: First administration of study treatment to 24 hours post last dosing of study treatment.
Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Secondary Outcomes
- Change From Baseline in Seated Diastolic Blood Pressure at Week 8(Baseline and week 8)
- Change From Baseline in Seated Systolic Blood Pressure at Week 8(Baseline and week 8)
- Seated DBP Control Rate at Trough After 8 Weeks(week 8)
- Seated SBP Control Rate at Trough After 8 Weeks(Week 8)
- Change From Baseline in Seated Diastolic Blood Pressure(Baseline and week 20 / week 48)
- Change From Baseline in Seated Systolic Blood Pressure(Baseline and week 20 / week 48)
- Seated DBP Control Rate at Trough After 6 and 12 Months(6 months and 12 months)
- Seated SBP Control Rate at Trough After 6 and 12 Months(6 months and 12 months)
- Seated DBP Response Rate at Trough(6 months and 12 months)
- Seated SBP Response Rate at Trough(6 months and 12 months)
- Seated Blood Pressure Normalisation at Trough(6 months and 12 months)