Hydrochlorothiazide (+) Losartan Potassium vs. Amlodipine Comparative Study (0954A-314)

Phase 4

Completed

• Conditions: Essential Hypertension

• Registration Number: NCT00157963
• Lead Sponsor: Organon and Co

Brief Summary

An efficacy and safety study of hydrochlorothiazide (+) losartan potassium compared to amlodipine at week 12 in Korean patients with essential hypertension

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-05
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Primary Completion: 2006-02-08
• Study Completion: 2006-02-08
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• Patients of age 20 70 75 with essential hypertension
• SiDBP 90 ~ 114mmHg at V1 & V2

Exclusion Criteria

• Patient has known or suspected secondary hypertension
• Patient has a history of malignant hypertension (SiSBP > 210mmHg)
• Individuals has a known sensitivity or intolerance to HCTZ or any AIIAs, or any sulfonamide-derived drugs.
• Patient has shown significant abnormal laboratory evaluations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Antihypertensive efficacy of 12 weeks of treatment with hydrochlorothiazide (+) losartan potassium/amlodipine

Secondary Outcome Measures

Name	Time	Method
Safety/Tolerability