Study to Evaluate the Effect of the Treatment With Micardis® or MicardisPlus® on Blood Pressure

Boehringer Ingelheim1,527 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,527

Conditions

Hypertension

Interventions

Micardis®DRUG

MicardisPlus®DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 18 years * Hypertension * Diabetes mellitus Exclusion Criteria: * Age \< 18 years

Outcomes

Primary Outcomes

Change from Baseline in systolic blood pressure (SBP)

Time frame: Baseline, after 6 months

Change from Baseline in diastolic blood pressure (DBP)

Time frame: Baseline, after 6 months

Secondary Outcomes

Assessment of efficacy by investigator on a 6-point scale

Time frame: after 6 months

Assessment of metabolic effect on a 3-point scale

Time frame: after 6 months

Change from Baseline in laboratory parameters

Metabolic parameters - Triglyceride, total cholesterol, blood glucose, insulin, HOMA-Index, HbA1c

Time frame: Baseline, after 6 months

Assessment of tolerability by investigator on a 5-point scale

Time frame: after 6 months

Number of patients with adverse events

Time frame: up to 6 months

Data from ClinicalTrials.gov

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