Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients
- Registration Number
- NCT01200407
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Hypertensive Filipino patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 615
- 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
- Patients with contraindications to any of the component of the fixed drug (amlodipine or olmesartan medoxomil) or with malignant or secondary hypertension
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Filipino Hypertensive patients Amlodipine + Olmesartan medoxomil Male and Female, 18 to 65 year old Filipino hypertensive patients prescribed by their doctors with Normetec
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to 28 days after last study drug administration (Week 12) An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last study drug administration (Week 12) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF) Baseline, Week 12
- Secondary Outcome Measures
Name Time Method Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF Baseline, Week 4, Week 8, Week 12 Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF Baseline, Week 12 Based on JNC VII, the ultimate public health goal of antihypertensive therapy is to reduce cardiovascular and renal morbidity and mortality. The JNC VII recommended BP goal is \<140/90 mmHg and \<130/80 mmHg for participants with diabetes.
Related Research Topics
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Trial Locations
- Locations (16)
Private Clinic
🇵🇭Tuguegarao City, Philippines
Metropolitan Medical Center Institutional Review Board
🇵🇭Manila, Philippines
Pines City Doctors Hospital
🇵🇭Baguio, Philippines
Isaac and Catalina Medical Center
🇵🇭Manila, Philippines
Dr. Agnes Vargas
🇵🇭Pasig Ciy, Philippines
Private cCinic
🇵🇭Pasig, Philippines
Angono Medics
🇵🇭Rizal, Philippines
Priavte Clinic
🇵🇭Tuguegarao City, Philippines
Makati Medical Center
🇵🇭Makati City, Philippines
Healthway Medical Clinic
🇵🇭Manila, Philippines
Metropolitan Medical Center
🇵🇭Manila, Philippines
The Medical City
🇵🇭Manila, Philippines
Lorma Medical Center
🇵🇭San Fernando City, LA Union, Philippines
Holy Child Hospital
🇵🇭Taclobo, Dumaguete City, Negros Oriental, Philippines
Jesus Nazarene General Hospital
🇵🇭Lingayen, Pangasinan, Philippines
Armed Forces of the Philippines Medical Center
🇵🇭Quezon City, Philippines