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

NCT ID: NCT00157963

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-05

Study Completion Date

2006-02-08

Brief Summary

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

Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type RESULT
PMID: 19949604 (View on PubMed)

Other Identifiers

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2005_067

Identifier Type: -

Identifier Source: secondary_id

0954A-314

Identifier Type: -

Identifier Source: org_study_id

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