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NCT00097955 Clinical Trial

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

Diabetic Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00097955
Other study ID # CSPP100C2201
Secondary ID
Status Completed
Phase Phase 2
First received December 1, 2004
Last updated May 15, 2017
Start date October 2004
Est. completion date April 2007

Study information
Verified date May 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Other known NCT identifiers
  • NCT00219206

Recruitment information / eligibility
Status Completed
Enrollment 496
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Hypertension

- Elevated urinary protein levels

- Confirmed type 2 diabetes

Exclusion Criteria:

- Certain diseases

- Uncontrolled diabetes

- Type 1 diabetes

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• aliskiren

Locations
Country Name City State
Canada Investigative Site Quebec
Denmark Investigative Site Hillerod
France Investigative Site Paris
Greece Investigative Site Athens
Italy Investigative Site Rome
Netherlands Investigative Site Rotterdam
Romania Investigative Site Bucharest
Russian Federation Investigative Site Moscow
Spain Investigative Site Madrid
United Kingdom Investigative Site London
United States Novartis Pharmaceuticals East Hanover New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in urinary albumin creatinine ratio after 24 weeks
Secondary Equal/more than 50% reduction from baseline in urinary albumin creatinine ratio after 24 weeks
Secondary Change from baseline in urinary albumin excretion rate after 24 weeks
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