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

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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Telmisartan

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim:

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

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, see Learn About Clinical Studies.

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

Investigators


Study Chair:	Boehringer Ingelheim	Boehringer Ingelheim

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:


Telmisartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Antihypertensive Agents	Cardiovascular Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015