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Post-marketing Surveillance Study With MicardisPlus® in Treatment of Morning Hypertension (Self-monitored by Patient)

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: NCT02243566
Recruitment Status : Completed
First Posted : September 18, 2014
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The purpose of the study was to examine the effect of six- to eight-week treatment with MicardisPlus® on blood pressure and the effect of patient self-monitoring on blood pressure control. In addition, the post-marketing surveillance study offered the possibility to obtain information about the influence on different laboratory parameters during treatment with MicardisPlus® from an unselected patient group under office conditions

Condition or disease Intervention/treatment
Hypertension Drug: MicardisPlus®

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Study Type : Observational
Actual Enrollment : 2707 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Morning Hypertension and Patient Self-monitoring
Study Start Date : April 2006
Actual Primary Completion Date : January 2007

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Essential hypertension Drug: MicardisPlus®
Other Name: Telmisartan in combination with hydrochlorothiazide

Primary Outcome Measures :
  1. Changes in morning blood pressure (systolic and diastolic) [ Time Frame: Pre-dose, up to 8 weeks after start of treatment ]
  2. Changes from baseline in laboratory values [ Time Frame: Pre-dose, up to 8 weeks after start of treatment ]
  3. Investigator assessment of efficacy on a 5-point scale [ Time Frame: Up to 8 weeks after start of treatment ]
  4. Investigator assessment of influence on metabolism on a 3-point scale [ Time Frame: Up to 8 weeks after start of treatment ]
  5. Investigator assessment of tolerability on a 5-point scale [ Time Frame: Up to 8 weeks after start of treatment ]
  6. Number of patients with adverse events [ Time Frame: Up to 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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
Outpatients with essential hypertension

Inclusion Criteria:

  • Age > 18 years
  • Hypertension

Exclusion Criteria:

  • Age < 18 years

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02243566    
Other Study ID Numbers: 502.513
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Telmisartan, hydrochlorothiazide drug combination
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists