Study to Evaluate the Effect of the Treatment With Micardis® or MicardisPlus® on Blood Pressure
- Registration Number
- NCT02242864
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective was to evaluate the effect of the treatment with Micardis® or MicardisPlus® on blood pressure. Secondary objectives were the effect of Micardis® / MicardisPlus® on metabolic parameters (triglycerides, cholesterol, LDL blood glucose, insulin Homeostasis Model Assessment (HOMA)-index and HbA1c) in patients with essential hypertension and diabetes mellitus
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1527
Inclusion Criteria
- Age > 18 years
- Hypertension
- Diabetes mellitus
Exclusion Criteria
- Age < 18 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with hypertension and diabetes mellitus Micardis® - Patients with hypertension and diabetes mellitus MicardisPlus® -
- Primary Outcome Measures
Name Time Method Change from Baseline in systolic blood pressure (SBP) Baseline, after 6 months Change from Baseline in diastolic blood pressure (DBP) Baseline, after 6 months
- Secondary Outcome Measures
Name Time Method Number of patients with adverse events up to 6 months Assessment of metabolic effect on a 3-point scale after 6 months Change from Baseline in laboratory parameters Baseline, after 6 months Metabolic parameters - Triglyceride, total cholesterol, blood glucose, insulin, HOMA-Index, HbA1c
Assessment of tolerability by investigator on a 5-point scale after 6 months Assessment of efficacy by investigator on a 6-point scale after 6 months