Clinical trial NCT00613314: Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen
Official title: Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen (CENTER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Metabolic Syndrome X
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 15268
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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


Eligibility 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

Primary outcomes:
measure: Response Rate at the End of 30 Day Period
timeFrame: End of 30 day Period
measure: Response Rate at the End of 60 Day Period
timeFrame: At the end of 60 day period
measure: Change in Systolic Blood Pressure (SBP) From Baseline
timeFrame: Baseline and 60 days
measure: Change in Diastolic Blood Pressure (DBP) From Baseline
timeFrame: Baseline and 60 days
Secondary outcomes:
measure: Percentage of Patients With Presence of Metabolic Risk Factor
timeFrame: At the end of 60 day period
Other outcomes:
Locations:
city: Alaminos City, Pangasinan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Angeles City, Pampanga
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Angeles City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Antipolo City, Rizal
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Atabay, San Jose
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Bacoor, Cavite
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Baguio City, Benguet
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Balanga City, Bataan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Baliuag, Balacan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Baliuag, Bulacan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Bangued, Abra
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Batac, Ilocos Norte
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Batangas City, Batangas
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Batangas City. Batangas
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Bauan Batangas
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Bautista, Pangasinan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Binan, Laguna
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Bocaue, Bulacan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Butuan City, Agusan Del Norte
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Butuan City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Cabanatuan City, Nueva Ecija
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Cagayan De Oro City, Misamis Oriental
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Cagayan De Oro City, Misamis
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Cagayan De Oro, Misamis Oriental
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Cainta, Rizal
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Calamba CIty, Laguna
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Calamba, Misamis Occidental
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Calamban City, Laguna
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Camiling, Laguna
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Cando City, Ilocos Sur
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Cauayan City, Isabela
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Cavite City, Cavite
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Cebu City, Cebu
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Cruz, Manila
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Dagupan City, Pangasinan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Dasmarinas, Cavite
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: De Vera, Santiago City, Isabela
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Digolog City, Zamboanga Del Norte
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Dinalupihan, Bataan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Dipolog City, Zamboange Del Norte
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Ermita, Manila
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Espana, Manila
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: F Cayco Sampaloc, Manila
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Gapan City, Nueva Ecija
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Gingoog City, Misamis Oriental
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Greenhills, San Juan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Guagua, Pampanga
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Iba, Zambales
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Ibalong, LegazpiCity, Albay
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Igano, Molave, Zamboanga del Sur
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Ilgan City, Lanao Del Norte
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Iligan city, Lanao del Norte
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Iloilo City, Iloilo
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Imus, Cavite
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Kalibo, Aklan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Kalookan City, Tala
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Kalookan City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Kaloonkan City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Laoag City, Ilocos Norte
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Laog City, Ilocos Norte
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Lapu-lapu City, Cebu
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Las Pina City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Las Pinas City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Legazpi City, Albay
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Lemery, Batangas
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Limay, Bataan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Lipa City, Batangas
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Lucena City, Quezon
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Makati City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Malate, Manila
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Mandaluyong City, Edsa
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Mandaluyong City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Marikina City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Marilao, Bulacan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Masangkay Tondo, Manila
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Meycauayan, Bulacan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Morayta Sampaloc, Manila
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Munoz City, Nueva Ecija
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Muntinlupa City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Naga City, Camarines sur
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Naga City, Carmarines Sur
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Olonggapo City, Zambales
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Ormoc City, Leyte
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Oroquita City, Misamis Occidental
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Ozamis City, Misamis Occidental
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Ozamis City, Misamis
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Paranaque City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Pasay City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Pasig City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Pinamalaayan, Calapan City, Oriental Mindoro
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Pulilan, Bulacan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Quezon City, Diliman
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Roxas City, Capiz
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Roxas, Isabela
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Sampaloc, Manila
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: San Carlos City, Pangasinan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: San Fernanado City, Pampanga
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: San Fernando City, La Union
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: San Fernando City, Pampanga
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: San Miguel, Manila
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: San Pablo City, Laguna
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: San Pedro, Laguna
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Santa Cruz, Laguna
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Santa Maria, Bulacan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Santa Maria, Bulaccan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Santiago City, Isabela
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Sorsogon City, Sorsogon
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Surigao City, Surigao Del Norte
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Taal, Batangas
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Tacloban City, Leyte
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Taft Ave, Manila
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Taft, Manila
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Tagbilaran City, Bohol
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Tanauan City, Batangas
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Tarlac City, Tarlac
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Tondo, Manila
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Tuguegarao City, Cagayan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Urdaneta City, Pangasinan
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Valenzuela City
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Vigan City, Ilocos Sur
country: Philippines
facility: Boehringer Ingelheim Investigational Site
city: Vigan City. Ilocos Sur
country: Philippines
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: