Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

This study has been completed.

First Received on January 31, 2008. Last Updated on March 23, 2010 History of Changes

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00613314

Purpose

To determine the efficacy and safety of telmisartan-based treatment among patients with metabolic syndrome in actual setting in Philippines.

Condition
Hypertension Metabolic Syndrome X

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen (CENTER)

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure Metabolic Syndrome

Drug Information available for: Telmisartan

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Change in Systolic Blood Pressure (SBP) From Baseline [ Time Frame: Baseline SBP up to 60 days ]
Change in Diastolic Blood Pressure (DBP) From Baseline [ Time Frame: Baseline DBP up to 60 days ]

Enrollment:	14478
Study Start Date:	June 2007
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Primary care clinic

Criteria

Inclusion Criteria:

Age > 45 years
Increased waist circumference (>88.9cm [>35in] men, >78.7cm [>31in] for women)
Elevated triglycerides (>150mg/dl)
Low HDL cholesterol (<40mg/dl in men, <50mg/dl in women)
Hypertension (>130/>85mmHG)
Impaired fasting glucose (>110mg/dl) (8)
Hypertensive patient assessed to benefit from telmisartan based treatment

Exclusion Criteria:

Hypersensitivity to telmisartan, hydrochlorothiazide (HCTZ) and its excipients
<3 months myocardial infarction (MI), stroke or severe heart failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613314

Show 122 Study Locations

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:	NCT00613314 History of Changes
Other Study ID Numbers:	502.532
Study First Received:	January 31, 2008
Results First Received:	February 8, 2010
Last Updated:	March 23, 2010
Health Authority:	Philippines: Department of Health Bureau of Food and Drugs

Additional relevant MeSH terms:

Hypertension
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antihypertensive Agents
Telmisartan

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012