Combination of Benazepril Plus Hydrochlorothiazide in Chi... | NCT00367094

Studies
Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension

NCT00367094

Sponsor

Novartis

Status

Completed

Last Update Posted

Jul 9, 2007Estimated

Enrollment

296

Phase

Phase 3

Conditions

Hypertension

Interventions

Benazepril plus hydrochlorothiazide

Countries

China

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

Mar 2007

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

Jul 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 21, 2006

First Submission Date that Met QC Criteria

Aug 21, 2006

First Posted Date

Aug 22, 2006Estimated

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

Jul 6, 2007

Last Update Posted Date

Jul 9, 2007Estimated

Description Module

Brief Summary

This study will evaluate efficacy and safety data for benazepril/hydrochlorothiazide in adult Chinese patients with mild to moderate essential hypertension. Patients whose blood pressure is not adequately controlled with benazepril monotherapy during a 4 week run-in period will be randomly allocated to double blind treatment over 8 weeks with either a combination of benazepril/hydrochlorothiazide per day or continuation of benazepril per day.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

296

Name	Type	Description	Arm Group Labels	Other Names
Benazepril plus hydrochlorothiazide	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in diastolic blood pressure from baseline to week 8

Secondary Outcomes

Measure	Description	Time Frame
Change in systolic blood pressure from baseline to week 8
Proportion of patients with blood pressure less than 140/90 mmHg at week 8
Ambulant blood pressure monitoring profiles at baseline and week 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients, age 18 or older
Given informed consent
Diagnosed as having mild to moderate essential hypertension

Exclusion Criteria:

Severe hypertension
Significant preexisting cardiovascular and cerebrovascular disease
Diabetes mellitus type 1 or poorly controlled diabetes mellitus type II
Advanced renal impairment

Other protocol-defined inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis		Beijing			China

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

Intervention Browse Module

MeSH Terms

ID	Term
C044946	benazepril
D006852	Hydrochlorothiazide

Ancestor Terms

ID	Term
D002740	Chlorothiazide
D001581	Benzothiadiazines
D013449	Sulfonamides
D013450	Sulfones

Browse Leaves

Not provided

Browse Branches

Not provided