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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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00946829
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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 Intervention
Hypertension
 Drug: telmisartan

Study Type: Observational
Study Design: 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

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:
  • 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:
  • 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 ]

Enrollment: 18299
Study Start Date: January 2003
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00946829     History of Changes
Other Study ID Numbers: 502.425
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Canadian Institutes of Health Research
Colombia: National Institutes of Health
Czech Republic: State Institute for Drug Control
Ecuador: Public Health Ministry
Indonesia: National Agency of Drug and Food Control
Jordan: Ethical Committee
Lebanon: Ministry of Public Health
Mexico: Ministry of Health
Turkey: Ministry of Health
Venezuela: Rafael Rangel National Institute of Health
Yemen: Ministry of Public Health and Population

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 22, 2013