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OpenTrials
Completed

NCT Number: NCT02242864

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Hypertension
  • Diabetes mellitus

Exclusion criteria

  • Age < 18 years

Treatment and study plan

Micardis®

Drug

MicardisPlus®

Drug

Primary outcomes

  1. Change from Baseline in systolic blood pressure (SBP)

    Time frame: Baseline, after 6 months

  2. Change from Baseline in diastolic blood pressure (DBP)

    Time frame: Baseline, after 6 months

Secondary outcomes

  1. Assessment of efficacy by investigator on a 6-point scale

    Time frame: after 6 months

  2. Assessment of metabolic effect on a 3-point scale

    Time frame: after 6 months

  3. Change from Baseline in laboratory parameters

    Time frame: Baseline, after 6 months

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

  4. Assessment of tolerability by investigator on a 5-point scale

    Time frame: after 6 months

  5. Number of patients with adverse events

    Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Micardis® / MicardisPlus® Monitoring of Morning Hypertension and Metabolism II

Important dates

Study start
2006
Primary completion
2006
First posted
Sep 17, 2014
Registry last updated
Sep 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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