Clinical trial NCT01200407: Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients
Official title: AN OPEN LABEL, NON-INTERVENTIONAL STUDY OF THE SAFETY, TOLERABILITY, AND EFFICACY OF AMLODIPINE AND OLMESARTAN MEDOXOMIL (NORMETECTM) IN FILIPINO PATIENTS WITH HYPERTENSION: A POST MARKETING SURVEILLANCE STUDY
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypertension
Keywords: Hypertension
fixed drug combination
Filipinos
Amlodipine
Olmesartan medoxomil
uncontrolled hypertension
difficult to treat hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 615
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Filipino Hypertensive patients ages 18-65 years old

Brief summary: The purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Hypertensive Filipino patients.


Eligibility criteria: Inclusion Criteria:

* Filipino hypertensive subjects ages 18-65 years old whether naive or currently taking any other anti-hypertensive or those on monotherapy using CCBs or ARBs whom they want to shift on a fixed dose combination drug

Exclusion Criteria:

* Patients with contraindications to any of the component of the fixed drug (amlodipine or olmesartan medoxomil) or with malignant or secondary hypertension

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last study drug administration (Week 12)
measure: Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: San Fernando City
country: Philippines
facility: Lorma Medical Center
state: LA Union
city: Taclobo, Dumaguete City
country: Philippines
facility: Holy Child Hospital
state: Negros Oriental
city: Albay
country: Philippines
facility: Private Clinic
city: Angono
country: Philippines
facility: Private Clinic
city: Baguio City
country: Philippines
facility: Private Clinic
city: Baguio
country: Philippines
facility: Pines City Doctors Hospital
city: Bulacan
country: Philippines
facility: Private Clinic
city: Calamba
country: Philippines
facility: Private Clinic
city: Cavite
country: Philippines
facility: Private Clinic
city: Cebu City
country: Philippines
facility: Private Clinic
city: Cebu
country: Philippines
facility: Private Clinic
city: Dagupan
country: Philippines
facility: Private Clinic
city: Davao City
country: Philippines
facility: Private Clinic
city: Davao
country: Philippines
facility: Private Clinic
city: Eastwood
country: Philippines
facility: Private Clinic
city: Iloilo City
country: Philippines
facility: Private Clinic
city: Iloilo
country: Philippines
facility: Private Clinic
city: Isabela
country: Philippines
facility: Private Clinic
city: Kalibo Aklan
country: Philippines
facility: Private Clinic
city: Laguna
country: Philippines
facility: Private Clinic
city: Laoag
country: Philippines
facility: Private Clinic
city: Lingayen, Pangasinan
country: Philippines
facility: Jesus Nazarene General Hospital
city: Makati City
country: Philippines
facility: Makati Medical Center
city: Makati City
country: Philippines
facility: Private Clinic
city: Makati
country: Philippines
facility: Private Clinic
city: Mandaluyong
country: Philippines
facility: Private Clinic
city: Manila
country: Philippines
facility: Healthway Medical Clinic
city: Manila
country: Philippines
facility: Isaac and Catalina Medical Center
city: Manila
country: Philippines
facility: Metropolitan Medical Center Institutional Review Board
city: Manila
country: Philippines
facility: Metropolitan Medical Center
city: Manila
country: Philippines
facility: Private Clinic
city: Manila
country: Philippines
facility: The Medical City
city: Marikina City
country: Philippines
facility: Private Clinic
city: Marikina
country: Philippines
facility: Private Clinic
city: Metro Manila
country: Philippines
facility: Private Clinic
city: Muntinlupa
country: Philippines
facility: Private Clinic
city: Nueva Vizcaya
country: Philippines
facility: Private Clinic
city: Olongapo
country: Philippines
facility: Private Clinic
city: Pampanga
country: Philippines
facility: Private Clinic
city: Paranaque
country: Philippines
facility: Private Clinic
city: Parañaque
country: Philippines
facility: Private Clinic
city: Pasay
country: Philippines
facility: Private Clinic
city: Pasig City
country: Philippines
facility: Private Clinic
city: Pasig Ciy
country: Philippines
facility: Dr. Agnes Vargas
city: Pasig
country: Philippines
facility: Private cCinic
city: Pasig
country: Philippines
facility: Private Clinic
city: Puerto Princesa
country: Philippines
facility: Private Clinic
city: Quezon City
country: Philippines
facility: Armed Forces of the Philippines Medical Center
city: Quezon City
country: Philippines
facility: Private Clinic
city: Rizal
country: Philippines
facility: Angono Medics
city: San Juan
country: Philippines
facility: Private Clinic
city: Tacloban
country: Philippines
facility: Private Clinic
city: Taguig
country: Philippines
facility: Private Clinic
city: Tarlac
country: Philippines
facility: Private Clinic
city: Tugegarao
country: Philippines
facility: Private Clinic
city: Tuguegarao City
country: Philippines
facility: Priavte Clinic
city: Tuguegarao City
country: Philippines
facility: Private Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: