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Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00613314
First Posted: February 13, 2008
Last Update Posted: May 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  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:
  • Response Rate at the End of 30 Day Period [ Time Frame: End of 30 day Period ]

    Response rate of Blood Pressure assessed in the following categories:

    • Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline
    • Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline Sitting BP normalization < 130 mmHg and DBP < 85 mmHg

  • Response Rate at the End of 60 Day Period [ Time Frame: At the end of 60 day period ]

    Response rate on Blood Pressure:

    1. Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline.
    2. Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline.
    3. Sitting BP normalization < 130 mmHg and DBP < 85 mmHg

  • Change in Systolic Blood Pressure (SBP) From Baseline [ Time Frame: Baseline and 60 days ]
    Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)

  • Change in Diastolic Blood Pressure (DBP) From Baseline [ Time Frame: Baseline and 60 days ]
    Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)


Secondary Outcome Measures:
  • Percentage of Patients With Presence of Metabolic Risk Factor [ Time Frame: At the end of 60 day period ]

    Presence of metabolic risk factor was identified by the existence of 3 out of the 5 risk factors namely:

    a.) presence of diabetes mellitus; b) presence of dyslipidemia; c) presence of albuminuria; d) presence of ventricular hypertrophy; and e) presence of co-morbidities,

    based on patients' Medical History



Enrollment: 15268
Study Start Date: June 2007
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613314


  Show 122 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00613314     History of Changes
Other Study ID Numbers: 502.532
First Submitted: January 31, 2008
First Posted: February 13, 2008
Results First Submitted: February 8, 2010
Results First Posted: March 5, 2010
Last Update Posted: May 26, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action