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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

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Daglutril

About this trial

This is an interventional treatment trial for Hypertension focused on measuring blood pressure, diabetic nephropathy, proteinuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Site 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00160225

First Posted

September 9, 2005

Last Updated

November 9, 2007

Sponsor

Solvay Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00160225

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Solvay Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

blood pressure, diabetic nephropathy, proteinuria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Daglutril

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Director Solvay

Organizational Affiliation

Solvay Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Site 1

City

Ranica

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

24622263

Citation

Parvanova A, van der Meer IM, Iliev I, Perna A, Gaspari F, Trevisan R, Bossi A, Remuzzi G, Benigni A, Ruggenenti P; Daglutril in Diabetic Nephropathy Study Group. Effect on blood pressure of combined inhibition of endothelin-converting enzyme and neutral endopeptidase with daglutril in patients with type 2 diabetes who have albuminuria: a randomised, crossover, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2013 Sep;1(1):19-27. doi: 10.1016/S2213-8587(13)70029-9. Epub 2013 Jun 13.

Results Reference

derived

Learn more about this trial

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

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