Effects of Amlodipine/Benazepril on Albuminuria in Hypert... | NCT00136773

Studies
Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus

NCT00136773

Sponsor

Novartis

Status

Completed

Last Update Posted

Mar 9, 2011Estimated

Enrollment

332Actual

Phase

Phase 4

Conditions

Albuminuria

Interventions

amlodipine/benazepril

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

Mar 2008

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

Apr 2003

Primary Completion Date

Oct 2005Actual

Completion Date

Nov 2005Actual

First Submitted Date

Aug 25, 2005

First Submission Date that Met QC Criteria

Aug 25, 2005

First Posted Date

Aug 29, 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

Mar 8, 2011

Last Update Posted Date

Mar 9, 2011Estimated

Description Module

Brief Summary

Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk factor for kidney disease. Aggressive blood pressure reduction is an important strategy to protect the kidney and reduce urinary protein which develops with kidney disease. This study will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary protein in hypertensive subjects with type 2 diabetes mellitus.

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

332Actual

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in the urine albumin/creatinine ratio after 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of patients who have progressed to diabetic kidney disease (urine albumin/creatinine ratio ≥ 300 µg/mg creatinine) after 52 weeks
Change from baseline in the ratio of urine albumin/creatinine ratio an estimate of kidney function after 52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mild to moderate hypertension
Type 2 diabetes mellitus
Presence of protein in the urine (albuminuria)

Exclusion Criteria:

Kidney disease not caused by diabetes or hypertension
Renal artery stenosis
Myocardial infarction or stroke within the last 6 months
Type 1 diabetes mellitus
Pregnant or lactating females
Cancer within the last 5 years

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D000419	Albuminuria
D003924	Diabetes Mellitus, Type 2
D006973	Hypertension

Ancestor Terms

ID	Term
D011507	Proteinuria
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

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