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Clinical EvaluatioN of TElmisartan-Based Antihypertensive Regimen
This study has been completed.
Sponsored by: 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 Phase
Hypertension
Metabolic Syndrome X
 Phase IV

MedlinePlus related topics: High Blood Pressure Metabolic Syndrome
Drug Information available for: Telmisartan
U.S. FDA Resources
Study Type: Observational
Official Title: Clinical EvaluatioN of TElmisartan-Based Antihypertensive Regimen (CENTER)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Resp rates will be assessed end 4 wk & 8 wk treatment period. Sitting SBP <130mmHg and/or a reduction of >20 mmHg frm baseline Sitting DBP <85mmHg and/or a reduction of >10 mmHg frm baseline Sitting BP <130 mmHg & DBP >85 mmHG Safety AE MI,stroke,hosp

Estimated Enrollment: 16000
Estimated Study Completion Date: September 2008
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, HCTZ and its excipients
  • <3 months MI, stroke or severe heart failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613314

  Show 126 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. (Phil) Inc.
  More Information

Study ID Numbers: 502.532
Study First Received: January 31, 2008
Last Updated: May 9, 2008
ClinicalTrials.gov Identifier: NCT00613314  
Health Authority: Philippines: Department of Health Bureau of Food and Drugs

Study placed in the following topic categories:
Hyperinsulinism
Metabolic Diseases
Metabolic Syndrome X
Syndrome X
Vascular Diseases
Telmisartan
 Insulin Resistance
Angiotensin II
Metabolic disorder
Glucose Metabolism Disorders
Abdominal obesity metabolic syndrome
Hypertension

Additional relevant MeSH terms:
Angiotensin II Type 1 Receptor Blockers
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Syndrome
 Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 13, 2009



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