NCT00160225

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

November 14, 2007

Status Verified

November 1, 2007

First QC Date

September 9, 2005

Last Update Submit

November 9, 2007

Conditions

Hypertension

Keywords

blood pressure, diabetic nephropathy, proteinuria

Interventions

DaglutrilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • known secondary hypertension
  • decompensated congestive heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 1

Ranica, Italy

Location

Related Publications (1)

  • 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.

    PMID: 24622263DERIVED

MeSH Terms

Conditions

HypertensionDiabetic NephropathiesProteinuria

Interventions

SLV 306

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

July 1, 2005

Last Updated

November 14, 2007

Record last verified: 2007-11

Locations

IT(1)