An Open-Label, Long-term (52-week), Safety Trial of the Fixed Dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 12.5mg and Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg in Patients With Essential Hypertension - Efficacy and Safety Evaluation
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The objective of this trial is to assess the safety and efficacy of 52 weeks of open-label treatment with the fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg and telmisartan 40 mg plus HCTZ 12.5 mg in patients with essential hypertension.
Detailed Description
This is a multi-centre study with three centres participating with a target of 30 to 90 patients entering the maintenance period and 20-60 patients completing long-term treatment per centre. The recruitment period will be about three months from the start of the study. Study Hypothesis: The primary objective of this study is to demonstrate the long-term safety of a fixed dose combination of telmisartan/HCTZ fixed-dose combination treatment. This study has no control group; therefore, no hypothesis testing will be performed. Comparison(s): This study has no control group.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis)
Time Frame: 52 weeks
Incidence of adverse events
Time Frame: 52 weeks
Changes in electrocardiogram (ECG)
Time Frame: 52 weeks
Changes in blood pressure and pulse rate
Time Frame: 52 weeks
Secondary Outcomes
- Seated blood pressure (BP) normality criteria(after 12 and 52 weeks)
- Changes in seated SBP(after 12 and 52 weeks)
- Seated DBP response rate(after 12 and 52 weeks)
- Seated SBP response rate(after 12 and 52 weeks)
- Changes in seated DBP(after 12 and 52 weeks)
- Seated Diastolic Blood Pressure (DBP) control rate(after 12 and 52 weeks)
- Seated Systolic Blood Pressure (SBP) control rate(after 12 and 52 weeks)