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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.
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: September 9, 2005
Last updated: November 9, 2007
Last verified: November 2007
This study is to evaluate the end of treatment effect of Daglutril compared to placebo on top of losartan.

Condition Intervention Phase
Drug: Daglutril
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00160225

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00160225     History of Changes
Other Study ID Numbers: S306.2.009
Study First Received: September 9, 2005
Last Updated: November 9, 2007

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

Additional relevant MeSH terms:
Kidney Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017