NCT00092209

Brief Summary

The purpose of this study is to evaluate antihypertensive (lowering blood pressure) effectiveness of three combinations of approved study drugs compared to both study drugs being given alone.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
840

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Apr 2002

Shorter than P25 for phase_3 hypertension

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

April 1, 2002

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2004

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

September 21, 2004

Last Update Submit

February 3, 2022

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean trough SiDBP after 8 weeks of treatment

Secondary Outcomes (1)

  • Safety

Interventions

MK0954A, hydrochlorothiazide (+) losartan potassiumDRUG
Comparator: placebo, losartan, hydrochlorothiazideDRUG

Eligibility Criteria

Age25 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese ancestry
  • Stable high blood pressure defined by the study criteria

You may not qualify if:

  • Pregnant or nursing
  • Significant concurrent kidney, liver, blood, or other disease
  • Recent heart attack or heart surgery
  • History of stroke, severe hypertension (high blood pressure), significant heart failure or cardiac arrhythmias
  • Significant lab abnormalities
  • Uncontrolled blood sugar
  • History of certain drug allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Saruta T, Ogihara T, Matsuoka H, Suzuki H, Toki M, Hirayama Y, Nonaka K, Takahashi K. Antihypertensive efficacy and safety of fixed-dose combination therapy with losartan plus hydrochlorothiazide in Japanese patients with essential hypertension. Hypertens Res. 2007 Aug;30(8):729-39. doi: 10.1291/hypres.30.729.

    PMID: 17917321BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

HydrochlorothiazideLosartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsImidazolesAzolesHeterocyclic Compounds, 1-RingTetrazoles

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2004

First Posted

September 24, 2004

Study Start

April 1, 2002

Primary Completion

November 1, 2002

Study Completion

November 1, 2002

Last Updated

February 15, 2022

Record last verified: 2022-02