Post Marketing Surveillance (PMS) Study to Assess Safety and Efficacy of Micardis in Patients With Essential Hypertension
- Registration Number
- NCT02245464
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of this PMS study was to monitor and assess the safety of Micardis tablets in patients with hypertension over a period of 6 years
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13066
Inclusion Criteria
- Male and female patients diagnosed with essential hypertension
- Patients without prior experience with Micardis tablet
Exclusion Criteria
- Known hypersensitivity to Micardis tablet
- Pregnancy or breastfeeding
- Biliary atresia
- Severe hepatic failure patients
- Severe renal failure patients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with essential hypertension Telmisartan -
- Primary Outcome Measures
Name Time Method Blood pressure reduction Up to 6 years Number of patients with adverse events Up to 6 years Assessment of efficacy based on subject's demographics on a two-point scale Up to 6 years Incidence rate of adverse events Up to 6 years based on demographic factors
Final assessment of efficacy on a 3-point scale Up to 6 years Assessment of safety on a 4-point scale Up to 6 years based on adverse events and changes in abnormality of clinical laboratory tests
- Secondary Outcome Measures
Name Time Method