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Study of Hypertensive Population Under Treatment With Telmisartan in Real Clinical Conditions With the Goal to Control Early Morning Blood Pressure Rise

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ClinicalTrials.gov Identifier: NCT00946829
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : July 27, 2009
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of the observational study is to ascertain the degree of blood pressure control in the early-morning hours after 8 weeks of treatment with Telmisartan/Telmisartan+Hydrochlorothiazide and during 44 weeks of follow-up, in patients with hypertension using home blood pressure measurements.

Condition or disease Intervention/treatment
Hypertension Drug: telmisartan

Study Design
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Study Type : Observational
Actual Enrollment : 18299 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Hypertensive Population Under Treatment With Micardis in Real Clinical Conditions With the Goal to Control the Early Morning BP Rise
Study Start Date : January 2003
Actual Primary Completion Date : May 2007

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change from baseline in mean early morning systolic blood pressure, mean early morning diastolic blood pressure, and degree of control. (6:00 to 11:59), BP < 135/85 mmHg. (HBPM: mean of morning measurements). [ Time Frame: 217 Weeks ]

Secondary Outcome Measures :
  1. Clinical control (office BP), response rates, reduction in office cuff systolic and diastolic BP. Office BP control criteria: BP < 140/90 mmHg. Pulse rate, pulse pressure, discontinuations and tolerability. [ Time Frame: 217 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic
Criteria

Inclusion Criteria:

  • Patients with mild to moderate essential hypertension and whose medical condition make them eligible for treatment with Telmisartan/Telmisartan+HCTZ

Exclusion Criteria:

  • Pre-menopausal women who had had no birth control, who are pregnant or nursing
  • Patients with advanced hepatic impairment, advanced renal impairment or both
  • Patients with functional class III or IV (NYHA) congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months
  • Patients with any valvular disease with hemodynamic repercussion
  • Patients receiving chronic administration of oral anticoagulants or digoxin
  • Patients with known hypersensitivity to any component in the formulation of Micardis / MicardisPlus
  • Patients with previous history of angioedema associated with ACE inhibitors
  • Patients with severe, uncontrolled hypertension or any form of secondary hypertension
  • Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00946829


Locations
Belgium
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site, Belgium
Canada
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site, Canada
Colombia
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site, Colombia
Czech Republic
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site, Czech Republic
Ecuador
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site, Ecuador
Indonesia
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site, Indonesia
Jordan
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site, Jordan
Lebanon
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site, Lebanon
Mexico
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site, Mexico
Turkey
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site, Turkey
Venezuela
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site, Venezuela
Yemen
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site, Yemen
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00946829     History of Changes
Other Study ID Numbers: 502.425
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: July 27, 2009
Last Verified: July 2009

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