A Multi-Center Study of Riociguat in Patients With Sickle Cell Diseases

Status Completed

Clinical Trial Summary

The proposed study is a Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel groups study aimed to evaluate the safety, tolerability and the efficacy of riociguat compared with placebo in patients with sickle cell disease (SCD).

Clinical Trial Description

This randomized study involves 12 weeks of treatment with riociguat pills or placebo pills, and a follow-up period of 30 days after treatment. The dose is adjusted every 2 weeks based on systolic blood pressure (SBP) and well-being assessed at that visit. Physical examinations, vital signs, blood tests and questionnaires will be performed at 2 week intervals during the double blinded study treatment. Echocardiogram, urine testing, six-minute walk distance and questionnaires will be assessed at the beginning and end of the treatment phase. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02633397
Study type	Interventional
Source	University of Pittsburgh
Contact
Status	Completed
Phase	Phase 2
Start date	April 11, 2017
Completion date	May 4, 2022

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