NCT00157963

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2006

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

September 7, 2005

Last Update Submit

August 13, 2024

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • Antihypertensive efficacy of 12 weeks of treatment with hydrochlorothiazide (+) losartan potassium/amlodipine

Secondary Outcomes (1)

  • Safety/Tolerability

Interventions

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

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.2009.39.4.151. Epub 2009 Apr 28.

    PMID: 19949604RESULT

MeSH Terms

Conditions

Essential Hypertension

Interventions

HydrochlorothiazideLosartanDuration of Therapy

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsImidazolesAzolesHeterocyclic Compounds, 1-RingTetrazolesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

February 5, 2005

Primary Completion

February 8, 2006

Study Completion

February 8, 2006

Last Updated

August 15, 2024

Record last verified: 2022-02