Back to resultsHydrochlorothiazide (+) Losartan Potassium vs. Amlodipine Comparative Study (0954A-314)
Primary Purpose
Essential Hypertension
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0954A; hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Antihypertensive efficacy of 12 weeks of treatment with hydrochlorothiazide (+) losartan potassium/amlodipine
Secondary Outcome Measures
Safety/Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00157963
Brief Title
Hydrochlorothiazide (+) Losartan Potassium vs. Amlodipine Comparative Study (0954A-314)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2005 (Actual)
Primary Completion Date
February 8, 2006 (Actual)
Study Completion Date
February 8, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
An efficacy and safety study of hydrochlorothiazide (+) losartan potassium compared to amlodipine at week 12 in Korean patients with essential hypertension
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0954A; hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 weeks
Primary Outcome Measure Information:
Title
Antihypertensive efficacy of 12 weeks of treatment with hydrochlorothiazide (+) losartan potassium/amlodipine
Secondary Outcome Measure Information:
Title
Safety/Tolerability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19949604
Citation
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.2009.39.4.151. Epub 2009 Apr 28.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Hydrochlorothiazide (+) Losartan Potassium vs. Amlodipine Comparative Study (0954A-314)
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