NCT00241007

Brief Summary

SAFETY EXTENSION STUDY TO THE CORE STUDY CVAH631C2301

Trial Health

87
On Track

Trial Health Score

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

Enrollment
836

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Dec 2003

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
Last Updated

November 8, 2011

Status Verified

October 1, 2005

Enrollment Period

1.2 years

First QC Date

October 14, 2005

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

HYPERTENSION, VALSARTAN

Outcome Measures

Primary Outcomes (1)

  • Adverse events and serious adverse events at each study visit for 54 weeks

Secondary Outcomes (5)

  • Change from baseline in diastolic blood pressure from baseline after 54 weeks

  • Change from baseline in systolic blood pressure from baseline after 54 weeks

  • Change from baseline in standing diastolic and systolic blood pressure after 54 weeks

  • Hematology and blood chemistries up to 54 weeks

  • Physical condition including pregnancy, pulse and weight at each study visit

Interventions

VALSARTAN, VALSARTAN+HYDROCHLOROTHIAZIDEDRUG

Eligibility Criteria

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

You may qualify if:

  • SUCCESSFUL COMPLETION OF STUDY CVAH631C2301

You may not qualify if:

  • NONE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY CHAIR

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

October 14, 2005

First Posted

October 18, 2005

Study Start

December 1, 2003

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

November 8, 2011

Record last verified: 2005-10

Locations

US(1)