Skip to main content
OpenTrials
Completed

NCT Number: NCT00613314

Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutritional and Metabolic Diseases Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site, Alaminos City, Pangasinan, Philippines

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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:

    • 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

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen (CENTER)

Important dates

Study start
2007
Primary completion
2008
First posted
Feb 13, 2008
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.