Trial intelligence / Profile preview

Ramipril and Valsartan in Hemodialysis Patients

NCT00732069Phase 2

Key facts

Status: Completed
Start: Aug 2008
Primary completion: Dec 2011
Countries: 1
Sponsor: Vanderbilt University
Modality: Small Molecules

Drugs: ramiprilvalsartan
Conditions: end stage renal disease (ESRD)

Overview

Phase 2, randomised, double-blind trial of ramipril and valsartan in end stage renal disease (ESRD) (6 arms), sponsored by Vanderbilt University. Primary endpoint: Interleukin 1 Beta at 1 week. Started Aug 2008; status: completed.

Design

6 arms

Study design: RandomizedDouble-blind

Sequence 1
Placebo -> Ramipril -> Valsartan
Sequence 2
Placebo -> Valsartan -> Ramipril
Sequence 3
Ramipril -> Placebo -> Valsartan
Sequence 4
Valsartan -> Placebo -> Ramipril
Sequence 5
Ramipril -> Valsartan -> Placebo
Sequence 6
Valsartan -> Ramipril -> Placebo

Endpoints

Primary

Interleukin 1 Beta1 week

Secondary

F2-Isoprostanes1 week

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