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Investigating the Effect of Telmisartan (Micardis®) on the Average 24h Blood Pressure of Therapy-naive and Therapy-experienced Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00879411
First Posted: April 10, 2009
Last Update Posted: March 28, 2014
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.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients

Condition Intervention
Hypertension Drug: Micardis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 24h BP Under Micardis in Daily Practice

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Efficacy (Change of Systolic Blood Pressure) [ Time Frame: baseline to 8 weeks ]
    Change from baseline in 24h systolic blood pressure (BP) at week 8

  • Efficacy (Change of Diastolic Blood Pressure) [ Time Frame: baseline to 8 weeks ]
    Change from baseline in 24h diastolic blood pressure (BP) at week 8


Secondary Outcome Measures:
  • Overall Tolerability Scale [ Time Frame: 8 weeks ]
    Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10


Enrollment: 670
Study Start Date: April 2009
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
arterial hypertension Drug: Micardis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hypertensive patients
Criteria

Inclusion criteria:

  1. Patients who have recently been diagnosed with hypertension
  2. Patients whose current blood pressure treatment are inadequate and needs to be revised are suitable for inclusion.

Exclusion criteria:

None (according to investigator)

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879411


Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00879411     History of Changes
Other Study ID Numbers: 502.582
First Submitted: April 9, 2009
First Posted: April 10, 2009
Results First Submitted: January 18, 2012
Results First Posted: May 15, 2012
Last Update Posted: March 28, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action