NCT00170989

Brief Summary

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
2,714

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_3 hypertension

Geographic Reach
2 countries

2 active sites

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

September 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

November 8, 2011

Status Verified

June 1, 2006

Enrollment Period

10 months

First QC Date

September 10, 2005

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

hypertensionhigh blood pressurevalsartanhydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

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

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

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

  • Diastolic blood pressure less than 90 mmHg after 8 weeks

  • Adverse events and serious adverse events at 8 weeks

Interventions

valsartan plus hydrochlorothiazideDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mild to moderate hypertension

You may not qualify if:

  • Severe hypertension
  • History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • Liver, kidney, or pancreas disease
  • Insulin dependent diabetes
  • Allergy to certain medications used to treat high blood pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Investigative Centers, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

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

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

September 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

November 8, 2011

Record last verified: 2006-06

Locations

DE(1)CH(1)