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Study to Evaluate the Effect of Micardis® / MicardisPlus® on Metabolic Parameters in Patients With Essential Hypertension and Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02242825
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : September 17, 2014
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Hypertension Drug: Micardis® Drug: MicardisPlus®

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Study Type : Observational
Actual Enrollment : 8148 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Micardis® / MicardisPlus® Monitoring of Morning Hypertension and Metabolism II
Study Start Date : January 2006
Actual Primary Completion Date : October 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Group/Cohort Intervention/treatment
Patients with hypertension and diabetes mellitus Drug: Micardis®
Drug: MicardisPlus®

Primary Outcome Measures :
  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, afterr 6 months ]

Secondary Outcome Measures :
  1. Assessment of efficacy by investigator on a 6-point scale [ Time Frame: after 6 months ]
  2. Assessment of metabolic effect on a 4-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 and 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hypertension and diabetes mellitus recruited by cardiologists, nephrologists or diabetologists

Inclusion Criteria:

  • Age > 18 years
  • Hypertension
  • Diabetes mellitus

Exclusion Criteria:

  • Age < 18 years

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02242825    
Other Study ID Numbers: 502.505
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Telmisartan, hydrochlorothiazide drug combination
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Natriuretic Agents
Physiological Effects of Drugs