Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria

NCT ID: NCT00097955

Last Updated: 2017-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

496 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-04-30

Brief Summary

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Study of the efficacy and safety of aliskiren when added to losartan and optimal antihypertensive therapy in patients with hypertension, type 2 diabetes, and kidney disorders to monitor improvement in any of these conditions.

Detailed Description

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Conditions

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Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Interventions

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aliskiren

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hypertension
* Elevated urinary protein levels
* Confirmed type 2 diabetes

Exclusion Criteria

* Certain diseases
* Uncontrolled diabetes
* Type 1 diabetes
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Investigative Site

Québec, , Canada

Site Status

Investigative Site

Hillerød, , Denmark

Site Status

Investigative Site

Paris, , France

Site Status

Investigative Centers, , Germany

Site Status

Investigative Site

Athens, , Greece

Site Status

Investigative Site

Rome, , Italy

Site Status

Investigative Site

Rotterdam, , Netherlands

Site Status

Investigative Site

Bucharest, , Romania

Site Status

Investigative Site

Moscow, , Russia

Site Status

Investigative Site

Madrid, , Spain

Site Status

Investigative Site

London, , United Kingdom

Site Status

Countries

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United States Canada Denmark France Germany Greece Italy Netherlands Romania Russia Spain United Kingdom

References

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Persson F, Lewis JB, Lewis EJ, Rossing P, Hollenberg NK, Parving HH; AVOID Study Investigators. Impact of baseline renal function on the efficacy and safety of aliskiren added to losartan in patients with type 2 diabetes and nephropathy. Diabetes Care. 2010 Nov;33(11):2304-9. doi: 10.2337/dc10-0833. Epub 2010 Aug 6.

Reference Type DERIVED
PMID: 20693353 (View on PubMed)

Parving HH, Persson F, Lewis JB, Lewis EJ, Hollenberg NK; AVOID Study Investigators. Aliskiren combined with losartan in type 2 diabetes and nephropathy. N Engl J Med. 2008 Jun 5;358(23):2433-46. doi: 10.1056/NEJMoa0708379.

Reference Type DERIVED
PMID: 18525041 (View on PubMed)

Other Identifiers

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CSPP100C2201

Identifier Type: -

Identifier Source: org_study_id

NCT00219206

Identifier Type: -

Identifier Source: nct_alias

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