NCT00311740

Brief Summary

The purpose of this study is to compare the effect of the fixed combination of valsartan+hydrochlorothiazide (HCTZ) on blood pressure reduction with valsartan and HCTZ alone and whether the combination treatments are safe and well tolerated. The study aims to establish a dose response relationship for both monotherapies and the combinations. This study is being conducted in Japan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
582

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

April 4, 2006

Last Update Submit

February 21, 2017

Conditions

Hypertension

Keywords

Hypertension,Valsartan,Hydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcomes (5)

  • Change from baseline in systolic blood pressure after 8 weeks

  • Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks

  • Change from baseline in standing diastolic blood pressure after 8 weeks

  • Change from baseline in standing systolic blood pressure after 8 weeks

  • Adverse events and serious adverse events at each study visit for 8 weeks

Interventions

ValsartanDRUG
HydrochlorothiazideDRUG

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Essential hypertension measured by mercury sphygmomanometer
  • Outpatients

You may not qualify if:

  • Secondary hypertension or suspected of having secondary hypertension.
  • A history of malignant hypertension
  • Severe hypertension
  • Significant heart, renal, hepatic diseases or significant cerebrovascular disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

Tokyo, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

ValsartanHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Novartis Pharmaceuticals

    Novatis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 6, 2006

Study Start

March 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

JP(1)