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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00097955

Enrollment

496

Registered

2004-12-02

Start date

2004-10-31

Completion date

2007-04-30

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Keywords

diabetes, nephropathy, hypertension, aliskiren, losartan

Brief summary

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.

Interventions

DRUGaliskiren

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Certain diseases * Uncontrolled diabetes * Type 1 diabetes

Design outcomes

Primary

Measure	Time frame
Change from baseline in urinary albumin creatinine ratio after 24 weeks	—

Secondary

Measure	Time frame
Equal/more than 50% reduction from baseline in urinary albumin creatinine ratio after 24 weeks	—
Change from baseline in urinary albumin excretion rate after 24 weeks	—

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026