Study to Evaluate the Efficacy and Safety of Daglutril Compared to Placebo on Top of Losartan in Type 2 Diabetics With Overt Nephropathy and Well Controlled Hypertension

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00160225
First received: September 9, 2005
Last updated: November 9, 2007
Last verified: November 2007
  Purpose

This study is to evaluate the end of treatment effect of Daglutril compared to placebo on top of losartan.


Condition Intervention Phase
Hypertension
Drug: Daglutril
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Two-Treatment and Two-Period Cross-Over, Mono-Center Study to Evaluate the Efficacy and Safety of Daglutril 300 mg Once Daily Compared to Placebo on Top of Losartan in Type 2 Diabetics With Overt Nephropathy and Well Controlled Hypertension

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • treated with optimized dose of losartan (constant dose for at least four weeks before randomization and throughout the whole study period) for at least four weeks
  • urinary albumin excretion ≥ 20 and < 1000 µg/min
  • sitting systolic/diastolic blood pressure (SBP/DBP) < 140/90 mmHg at the end of placebo run-in phase

Exclusion Criteria:

  • known secondary hypertension
  • decompensated congestive heart failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160225

Locations
Italy
Site 1
Ranica, Italy
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00160225     History of Changes
Other Study ID Numbers: S306.2.009, 2004-001980-24
Study First Received: September 9, 2005
Last Updated: November 9, 2007
Health Authority: United States: Food and Drug Administration
Italy: Ministry of Health

Keywords provided by Solvay Pharmaceuticals:
blood pressure, diabetic nephropathy, proteinuria

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 15, 2014