NCT00338936

Brief Summary

This study is designed to provide long-term safety and efficacy data for the combination doses of VAH (VAL/ HCTZ) 40/6.25mg and 80/12.5mg in essential hypertensive patients. The 350 patients (approximately) who have successfully finished the core trial CVAH631B1303 and signed consent for the extension will be enrolled into this study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
362

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started May 2006

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

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

1.3 years

First QC Date

June 16, 2006

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

HypertensionValsartanHydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

  • Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks.

Secondary Outcomes (5)

  • Change from baseline in average sitting diastolic blood pressure after 52 weeks

  • Change from baseline in average sitting systolic blood pressure after 52 weeks

  • Change from baseline in average standing diastolic blood pressure after 52 weeks

  • Change from baseline in average standing systolic blood pressure after 52 weeks

  • Laboratory abnormalities after 52 weeks

Interventions

Valsartan + HydrochlorothiazideDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients who successfully complete the core study (Protocol 1303)
  • Outpatients

You may not qualify if:

  • Presence of crucial protocol violation in Protocol 1303
  • Patients who experienced any adverse events considered serious and drug related in Protocol 1303.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 Pharma Ag

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

May 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

November 8, 2011

Record last verified: 2011-11