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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:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00879411
First received: April 9, 2009
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  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:

Drug Information available for: Telmisartan
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879411

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00879411     History of Changes
Other Study ID Numbers: 502.582
Study First Received: April 9, 2009
Results First Received: January 18, 2012
Last Updated: May 18, 2012
Health Authority: Switzerland: Laws and standards

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013