Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

N/ATerminatedNCT01200407

Pfizer615 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

615

Conditions

Hypertension

Interventions

Amlodipine + Olmesartan medoxomilDRUG

start dose is 5/20 mg, which can then be uptitrated to 5/40 mg up to 10/40 mg if BP goal is not reached during the 4 week follow-up

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (51)

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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.

Time frame: Baseline up to 28 days after last study drug administration (Week 12)

Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF)

Time frame: Baseline, Week 12

Secondary Outcomes

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF

Time frame: Baseline, Week 4, Week 8, Week 12

Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF

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.

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

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