Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00613314
First received: January 31, 2008
Last updated: May 18, 2012
Last verified: May 2012
  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:


Further study details as provided by Boehringer Ingelheim:

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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional 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: May 18, 2012
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 April 16, 2014