Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

Terminated

• Conditions: Hypertension
• Interventions: Drug: Amlodipine + Olmesartan medoxomil

• 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

Study Timeline

• Study Start: 2010-06-09
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Primary Completion: 2014-01-04
• Study Completion: 2014-01-04
• Results First Submitted: 2021-06-12
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-26
• Last Update Submitted: 2021-07-26
• Results First Posted: 2021-08-17
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 615

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

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.

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