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Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

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ClinicalTrials.gov Identifier: NCT00613314
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : March 5, 2010
Last Update Posted : May 26, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

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

Condition or disease
Hypertension Metabolic Syndrome X

Study Type : Observational
Actual Enrollment : 15268 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen (CENTER)
Study Start Date : June 2007
Actual Primary Completion Date : April 2008





Primary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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 :
  1. 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




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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00613314     History of Changes
Other Study ID Numbers: 502.532
First Posted: February 13, 2008    Key Record Dates
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