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Riociguat for Sickle Cell Disease

Phase 2
Waitlist Available
Led By Mark Gladwin, MD
Research Sponsored by Mark Gladwin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Awards & highlights

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).

Eligible Conditions
  • Sickle Cell Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Incidence of Treatment Emergent Severe Adverse Events (SAE)
Secondary outcome measures
6-minute Walk Distance
Changes in Albumin/Creatinine Ratio
Changes in Blood Pressure as the Main Pharmacodynamic (MAP)
+19 more

Side effects data

From 2015 Phase 4 trial • 28 Patients • NCT02024386
17%
Phlebitis
17%
Dizziness
17%
Bronchospasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Riociguat 0.5 mg
Riociguat 1.0 mg
Control Arm

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RiociguatExperimental Treatment1 Intervention
Treatment Arm
Group II: PlaceboPlacebo Group1 Intervention
Placebo Arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Riociguat
2016
Completed Phase 4
~510

Find a Location

Who is running the clinical trial?

Mark GladwinLead Sponsor
2 Previous Clinical Trials
203 Total Patients Enrolled
Mark Gladwin, MDPrincipal Investigator - University of Pittsburgh
Western Psychiatric Institute & Clinic
University Of Miami School Of Medicine (Medical School)
N I H-W G Magnuson Cli Center (Residency)
4 Previous Clinical Trials
191 Total Patients Enrolled
~15 spots leftby Sep 2025
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