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NCT00157963 Clinical Trial

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

Essential Hypertension Clinical Trial

Official title:
A 12 Week, Open, Randomized, Parallel, Multicenter Study of Efficacy, Tolerability & Safety of Hydrochlorothiazide (+) Losartan Potassium Versus Amlodipine in Essential Hypertensive Patients.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00157963
Other study ID # 0954A-314
Secondary ID 2005_067
Status Completed
Phase Phase 4
First received
Last updated
Start date February 5, 2005
Est. completion date February 8, 2006

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 174
Est. completion date February 8, 2006
Est. primary completion date February 8, 2006
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• MK0954A; hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Chung JW, Lee HY, Kim CH, Seung IW, Shin YW, Jeong MH, Cho MC, Oh BH. Losartan/Hydrochlorothiazide fixed combination versus amlodipine monotherapy in korean patients with mild to moderate hypertension. Korean Circ J. 2009 Apr;39(4):151-6. doi: 10.4070/kcj — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Antihypertensive efficacy of 12 weeks of treatment with hydrochlorothiazide (+) losartan potassium/amlodipine
Secondary Safety/Tolerability
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