Study to Evaluate the Effect of Micardis® / MicardisPlus® on Metabolic Parameters in Patients With Essential Hypertension and Diabetes Mellitus
- Registration Number
- NCT02242825
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective is to evaluate the effect of the treatment with Micardis® or MicardisPlus® on blood pressure. Secondary objectives are the effect of Micardis® / MicardisPlus® on metabolic parameters (triglycerides, cholesterol, blood glucose and HbA1c) in patients with essential hypertension and diabetes mellitus
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8148
Inclusion Criteria
- Age > 18 years
- Hypertension
- Diabetes mellitus
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Exclusion Criteria
- Age < 18 years
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with hypertension and diabetes mellitus MicardisPlus® - Patients with hypertension and diabetes mellitus Micardis® -
- 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, afterr 6 months
- Secondary Outcome Measures
Name Time Method Assessment of metabolic effect on a 4-point scale after 6 months Assessment of efficacy by investigator on a 6-point scale after 6 months Assessment of tolerability by investigator on a 5-point scale after 6 months Change from Baseline in laboratory parameters Baseline, after 6 months Metabolic parameters - Triglyceride, total cholesterol, blood glucose and HbA1c
Number of patients with adverse events up to 6 months