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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

S

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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