NCT00171782

Brief Summary

A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2 hypertension and cardiovascular risk factors.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Feb 2004

Shorter than P25 for phase_4 hypertension

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

February 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

September 13, 2005

Last Update Submit

October 11, 2023

Conditions

HYPERTENSION

Keywords

HYPERTENSIONVALSARTANVALSARTAN AND HYDROCHLOROTHIAZIDERISK FACTORS

Outcome Measures

Primary Outcomes (1)

  • Change from baseline systolic blood pressure at 8 weeks

Secondary Outcomes (3)

  • Blood pressure less than 140/90 mmHg at 8 weeks

  • Reduction from baseline in diastolic blood pressure greater than or equal to 10 mmHg

  • Reduction from baseline in systolic blood pressure greater than or equal to 20 mmHg

Interventions

VALSARTAN+HYDROCHLOROTHIAZIDEDRUG

Eligibility Criteria

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

You may qualify if:

  • \- Patients who give consent
  • Men and women 18 to 80 years of age
  • Patients with hypertension (systolic \>159 mm, diastolic \>100 mm)
  • Patients meeting laboratory criteria

You may not qualify if:

  • \- Pregnant women
  • Women not using approved contraception methods
  • Secondary hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

February 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

October 12, 2023

Record last verified: 2023-10