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: April 30, 2014
Last verified: April 2014
  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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 30, 2014
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
Telmisartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014