Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Live in Patients With Essential Hypertension
Phase 4
Completed
- Conditions
- Hypertension
- Interventions
- Drug: Low dose of telmisartanDrug: High dose of telmisartan
- Registration Number
- NCT02242370
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to establish the effect on patient's quality of life scores.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3045
Inclusion Criteria
- Patients with Stage I essential Hypertension (diastolic blood pressure 90-99 mmHg, and/or systolic blood pressure 140-159 mmHg)
- Signed informed consent form
Exclusion Criteria
- Females of childbearing potential
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telmisartan low dose Low dose of telmisartan - Telmisartan high dose High dose of telmisartan -
- Primary Outcome Measures
Name Time Method Change in diastolic blood pressure Pre-dose, up to 6 weeks after start of treatment Change in systolic blood pressure Pre-dose, up to 6 weeks after start of treatment Changes from baseline in the quality of life (QOL) scores by patient self-assessment Pre-dose, 6 weeks after start of treatment
- Secondary Outcome Measures
Name Time Method Assessment of systolic blood pressure response rate Up to 6 weeks after start of treatment Change from baseline in pulse pressure Pre-dose, up to 6 weeks after start of treatment Number of patients with adverse events Up to 6 weeks Assessment of blood pressure control rate Up to 6 weeks after start of treatment Assessment of diastolic blood pressure response rate Up to 6 weeks after start of treatment