At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 130 enrolled
Drug / intervention
Riociguat +1 moredrug
Likely dose
Riociguat 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Assess the Safety, Tolerability, and Efficacy of Riociguat in Patients With Sickle Cell Diseases
In Brief
A Phase 2 clinical trial evaluating Riociguat and Placebo for Sickle Cell Disease. Completed, enrolled 130 participants across 20 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartApr 2017
Primary CompletionMay 2022
TodayJul 2026
First PostedDec 17, 2015
Enrollment StartApr 11, 2017
Primary CompletionMay 4, 2022
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 10.5 years ago
Interventions
Riociguatdrug
Riociguat 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg three times a day for 12 weeks
Placebodrug
Matching placebo to riociguat 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg three times a day for 12 weeks