A Study Comparing the Response of Patients With Hypertens... | NCT00171366

Studies
A Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril.

NCT00171366

Sponsor

Novartis

Status

Completed

Last Update Posted

Apr 6, 2016Estimated

Enrollment

1,422Actual

Phase

Phase 3

Conditions

Hypertension

Interventions

amlodipine/benazepril

Countries

United States

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

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2004

Primary Completion Date

Jul 2005Actual

Completion Date

Jul 2005Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 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

Apr 5, 2016

Last Update Posted Date

Apr 6, 2016Estimated

Name	Class
Pfizer	INDUSTRY

Description Module

Brief Summary

Comparison of the safety and efficacy of the combination of amlodipine/Benazepril to amlodipine monotherapy in patients with non-essential hypertension, not controlled on amlodipine alone.

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

1,422Actual

Name	Type	Description	Arm Group Labels	Other Names
amlodipine/benazepril	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in mean sitting diastolic blood pressure at week 6

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in mean sitting systolic blood pressure at week 6
Change from week 2 in mean sitting diastolic and systolic blood pressure at week 6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatients 18 years of age or older.
Male or female patients are eligible. Female patients must be either post-menopausal for one year or surgically sterile, or using effective, contraceptive methods such as barrier method with spermicide, or an intrauterine device.
Patients with essential hypertension as measured by a validated device

Exclusion Criteria:

Severe hypertension (DBP > 115 mmHg diastolic and/or SBP > 180 mmHg systolic).

Other protocol-defined exclusion criteria may apply.

Accepts Healthy Volunteers

Not provided

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	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Pharmaceuticals		East Hanover	New Jersey	07936	United States

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D006337	Heart Murmurs

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C044946	benazepril

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided