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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Solvay Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Cardiovascular Diseases
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014