Hypertension Clinical Trial
Official title:
Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen (CENTER)
| NCT number | NCT00613314 |
| Other study ID # | 502.532 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | January 31, 2008 |
| Last updated | April 30, 2014 |
| Start date | June 2007 |
To determine the efficacy and safety of telmisartan-based treatment among patients with metabolic syndrome in actual setting in Philippines.
| Status | Completed |
| Enrollment | 15268 |
| Est. completion date | |
| Est. primary completion date | April 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Philippines | Boehringer Ingelheim Investigational Site | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Philippines,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Response Rate at the 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 | No |
| Primary | Response Rate 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 | No |
| Primary | Change in Systolic Blood Pressure (SBP) From Baseline | Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period) | Baseline and 60 days | No |
| Primary | Change in Diastolic Blood Pressure (DBP) From Baseline | Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period) | Baseline and 60 days | No |
| Secondary | Percentage of Patients With Presence of Metabolic Risk Factor | 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 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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