Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

April 30, 2014 updated by: Boehringer Ingelheim

Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen (CENTER)

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

15268

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Philippines
- - Alaminos City, Pangasinan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Angeles City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Angeles City, Pampanga, Philippines
    - Boehringer Ingelheim Investigational Site
  - Antipolo City, Rizal, Philippines
    - Boehringer Ingelheim Investigational Site
  - Atabay, San Jose, Philippines
    - Boehringer Ingelheim Investigational Site
  - Bacoor, Cavite, Philippines
    - Boehringer Ingelheim Investigational Site
  - Baguio City, Benguet, Philippines
    - Boehringer Ingelheim Investigational Site
  - Balanga City, Bataan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Baliuag, Balacan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Baliuag, Bulacan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Bangued, Abra, Philippines
    - Boehringer Ingelheim Investigational Site
  - Batac, Ilocos Norte, Philippines
    - Boehringer Ingelheim Investigational Site
  - Batangas City, Batangas, Philippines
    - Boehringer Ingelheim Investigational Site
  - Batangas City. Batangas, Philippines
    - Boehringer Ingelheim Investigational Site
  - Bauan Batangas, Philippines
    - Boehringer Ingelheim Investigational Site
  - Bautista, Pangasinan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Binan, Laguna, Philippines
    - Boehringer Ingelheim Investigational Site
  - Bocaue, Bulacan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Butuan City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Butuan City, Agusan Del Norte, Philippines
    - Boehringer Ingelheim Investigational Site
  - Cabanatuan City, Nueva Ecija, Philippines
    - Boehringer Ingelheim Investigational Site
  - Cagayan De Oro City, Misamis, Philippines
    - Boehringer Ingelheim Investigational Site
  - Cagayan De Oro City, Misamis Oriental, Philippines
    - Boehringer Ingelheim Investigational Site
  - Cagayan De Oro, Misamis Oriental, Philippines
    - Boehringer Ingelheim Investigational Site
  - Cainta, Rizal, Philippines
    - Boehringer Ingelheim Investigational Site
  - Calamba CIty, Laguna, Philippines
    - Boehringer Ingelheim Investigational Site
  - Calamba, Misamis Occidental, Philippines
    - Boehringer Ingelheim Investigational Site
  - Calamban City, Laguna, Philippines
    - Boehringer Ingelheim Investigational Site
  - Camiling, Laguna, Philippines
    - Boehringer Ingelheim Investigational Site
  - Cando City, Ilocos Sur, Philippines
    - Boehringer Ingelheim Investigational Site
  - Cauayan City, Isabela, Philippines
    - Boehringer Ingelheim Investigational Site
  - Cavite City, Cavite, Philippines
    - Boehringer Ingelheim Investigational Site
  - Cebu City, Cebu, Philippines
    - Boehringer Ingelheim Investigational Site
  - Cruz, Manila, Philippines
    - Boehringer Ingelheim Investigational Site
  - Dagupan City, Pangasinan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Dasmarinas, Cavite, Philippines
    - Boehringer Ingelheim Investigational Site
  - De Vera, Santiago City, Isabela, Philippines
    - Boehringer Ingelheim Investigational Site
  - Digolog City, Zamboanga Del Norte, Philippines
    - Boehringer Ingelheim Investigational Site
  - Dinalupihan, Bataan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Dipolog City, Zamboange Del Norte, Philippines
    - Boehringer Ingelheim Investigational Site
  - Ermita, Manila, Philippines
    - Boehringer Ingelheim Investigational Site
  - Espana, Manila, Philippines
    - Boehringer Ingelheim Investigational Site
  - F Cayco Sampaloc, Manila, Philippines
    - Boehringer Ingelheim Investigational Site
  - Gapan City, Nueva Ecija, Philippines
    - Boehringer Ingelheim Investigational Site
  - Gingoog City, Misamis Oriental, Philippines
    - Boehringer Ingelheim Investigational Site
  - Greenhills, San Juan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Guagua, Pampanga, Philippines
    - Boehringer Ingelheim Investigational Site
  - Iba, Zambales, Philippines
    - Boehringer Ingelheim Investigational Site
  - Ibalong, LegazpiCity, Albay, Philippines
    - Boehringer Ingelheim Investigational Site
  - Igano, Molave, Zamboanga del Sur, Philippines
    - Boehringer Ingelheim Investigational Site
  - Ilgan City, Lanao Del Norte, Philippines
    - Boehringer Ingelheim Investigational Site
  - Iligan city, Lanao del Norte, Philippines
    - Boehringer Ingelheim Investigational Site
  - Iloilo City, Iloilo, Philippines
    - Boehringer Ingelheim Investigational Site
  - Imus, Cavite, Philippines
    - Boehringer Ingelheim Investigational Site
  - Kalibo, Aklan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Kalookan City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Kalookan City, Tala, Philippines
    - Boehringer Ingelheim Investigational Site
  - Kaloonkan City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Laoag City, Ilocos Norte, Philippines
    - Boehringer Ingelheim Investigational Site
  - Laog City, Ilocos Norte, Philippines
    - Boehringer Ingelheim Investigational Site
  - Lapu-lapu City, Cebu, Philippines
    - Boehringer Ingelheim Investigational Site
  - Las Pina City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Las Pinas City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Legazpi City, Albay, Philippines
    - Boehringer Ingelheim Investigational Site
  - Lemery, Batangas, Philippines
    - Boehringer Ingelheim Investigational Site
  - Limay, Bataan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Lipa City, Batangas, Philippines
    - Boehringer Ingelheim Investigational Site
  - Lucena City, Quezon, Philippines
    - Boehringer Ingelheim Investigational Site
  - Makati City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Malate, Manila, Philippines
    - Boehringer Ingelheim Investigational Site
  - Mandaluyong City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Mandaluyong City, Edsa, Philippines
    - Boehringer Ingelheim Investigational Site
  - Marikina City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Marilao, Bulacan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Masangkay Tondo, Manila, Philippines
    - Boehringer Ingelheim Investigational Site
  - Meycauayan, Bulacan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Morayta Sampaloc, Manila, Philippines
    - Boehringer Ingelheim Investigational Site
  - Munoz City, Nueva Ecija, Philippines
    - Boehringer Ingelheim Investigational Site
  - Muntinlupa City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Naga City, Camarines sur, Philippines
    - Boehringer Ingelheim Investigational Site
  - Naga City, Carmarines Sur, Philippines
    - Boehringer Ingelheim Investigational Site
  - Olonggapo City, Zambales, Philippines
    - Boehringer Ingelheim Investigational Site
  - Ormoc City, Leyte, Philippines
    - Boehringer Ingelheim Investigational Site
  - Oroquita City, Misamis Occidental, Philippines
    - Boehringer Ingelheim Investigational Site
  - Ozamis City, Misamis, Philippines
    - Boehringer Ingelheim Investigational Site
  - Ozamis City, Misamis Occidental, Philippines
    - Boehringer Ingelheim Investigational Site
  - Paranaque City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Pasay City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Pasig City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Pinamalaayan, Calapan City, Oriental Mindoro, Philippines
    - Boehringer Ingelheim Investigational Site
  - Pulilan, Bulacan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Quezon City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Quezon City, Diliman, Philippines
    - Boehringer Ingelheim Investigational Site
  - Roxas City, Capiz, Philippines
    - Boehringer Ingelheim Investigational Site
  - Roxas, Isabela, Philippines
    - Boehringer Ingelheim Investigational Site
  - Sampaloc, Manila, Philippines
    - Boehringer Ingelheim Investigational Site
  - San Carlos City, Pangasinan, Philippines
    - Boehringer Ingelheim Investigational Site
  - San Fernanado City, Pampanga, Philippines
    - Boehringer Ingelheim Investigational Site
  - San Fernando City, La Union, Philippines
    - Boehringer Ingelheim Investigational Site
  - San Fernando City, Pampanga, Philippines
    - Boehringer Ingelheim Investigational Site
  - San Miguel, Manila, Philippines
    - Boehringer Ingelheim Investigational Site
  - San Pablo City, Laguna, Philippines
    - Boehringer Ingelheim Investigational Site
  - San Pedro, Laguna, Philippines
    - Boehringer Ingelheim Investigational Site
  - Santa Cruz, Laguna, Philippines
    - Boehringer Ingelheim Investigational Site
  - Santa Maria, Bulacan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Santa Maria, Bulaccan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Santiago City, Isabela, Philippines
    - Boehringer Ingelheim Investigational Site
  - Sorsogon City, Sorsogon, Philippines
    - Boehringer Ingelheim Investigational Site
  - Surigao City, Surigao Del Norte, Philippines
    - Boehringer Ingelheim Investigational Site
  - Taal, Batangas, Philippines
    - Boehringer Ingelheim Investigational Site
  - Tacloban City, Leyte, Philippines
    - Boehringer Ingelheim Investigational Site
  - Taft Ave, Manila, Philippines
    - Boehringer Ingelheim Investigational Site
  - Taft, Manila, Philippines
    - Boehringer Ingelheim Investigational Site
  - Tagbilaran City, Bohol, Philippines
    - Boehringer Ingelheim Investigational Site
  - Tanauan City, Batangas, Philippines
    - Boehringer Ingelheim Investigational Site
  - Tarlac City, Tarlac, Philippines
    - Boehringer Ingelheim Investigational Site
  - Tondo, Manila, Philippines
    - Boehringer Ingelheim Investigational Site
  - Tuguegarao City, Cagayan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Urdaneta City, Pangasinan, Philippines
    - Boehringer Ingelheim Investigational Site
  - Valenzuela City, Philippines
    - Boehringer Ingelheim Investigational Site
  - Vigan City, Ilocos Sur, Philippines
    - Boehringer Ingelheim Investigational Site
  - Vigan City. Ilocos Sur, Philippines
    - Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	End of 30 day Period
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	At the end of 60 day period
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)	Baseline and 60 days
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)	Baseline and 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At the end of 60 day period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

May 26, 2014

Last Update Submitted That Met QC Criteria

April 30, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

502.532

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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