Hydrochlorothiazide (+) Losartan Potassium vs. Amlodipine Comparative Study (0954A-314)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension
Intervention: MK0954A; hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 weeks (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
An efficacy and safety study of hydrochlorothiazide (+) losartan potassium compared to
amlodipine at week 12 in Korean patients with essential hypertension
Clinical Details
Official title: A 12 Week, Open, Randomized, Parallel, Multicenter Study of Efficacy, Tolerability & Safety of Hydrochlorothiazide (+) Losartan Potassium Versus Amlodipine in Essential Hypertensive Patients.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Antihypertensive efficacy of 12 weeks of treatment with hydrochlorothiazide (+) losartan potassium/amlodipine
Secondary outcome: Safety/Tolerability
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: February 2005
Last updated: April 1, 2015
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