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

Solvay

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Daglutril

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160225

S306.2.009

2004-001980-24

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind