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CompletedNCT00092209Updated Feb 15, 2022

Antihypertensive Efficacy and Safety of Approved Drugs in Japanese Patients With Essential Hypertension (Banyu Study)(0954A-302)

A Phase 3 interventional study of MK0954A, hydrochlorothiazide (+) losartan potassium and Comparator: placebo, losartan, hydrochlorothiazide in Hypertension, sponsored by Organon and Co. Completed. Open to participants aged 25 Years to 74 Years. Per ClinicalTrials.gov, last updated 2022-02-15.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
840
Allocation
Randomized
Ages
25 Years to 74 Years
Sex
All
01

Study 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.

Read the detailed description

The duration of treatment is 3.5 months.

02

Conditions studied

03

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 840 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
840 participants

Interventions

  • DrugMK0954A, hydrochlorothiazide (+) losartan potassium
  • DrugComparator: placebo, losartan, hydrochlorothiazide
06

What researchers measure

Primary outcomes

  1. Mean trough SiDBP after 8 weeks of treatment

Secondary outcomes

  1. Safety

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 17917321 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00092209
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Sep 24, 2004
Start date
Apr 2002
Primary completion
Nov 2002
Completion
Nov 2002
Last update
Feb 15, 2022

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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