Hypertension and Cardiovascular Risk Factors | NCT00171782

Studies
Hypertension and Cardiovascular Risk Factors

NCT00171782

Sponsor

Novartis

Status

Completed

Last Update Posted

Oct 12, 2023Actual

Enrollment

76Actual

Phase

Phase 4

Conditions

HYPERTENSION

Interventions

VALSARTAN+HYDROCHLOROTHIAZIDE

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Dec 2004Actual

Completion Date

Dec 2004Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2023

Last Update Posted Date

Oct 12, 2023Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Name	Type	Description	Arm Group Labels	Other Names
VALSARTAN+HYDROCHLOROTHIAZIDE	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline systolic blood pressure at 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- Pregnant women
Women not using approved contraception methods
Secondary hypertension

Other protocol-defined exclusion criteria may apply.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided