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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02227472` - Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease
Recruiting	`NCT06301893` - Uganda Sickle Surveillance Study (US-3)
Recruiting	`NCT04398628` - ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Completed	`NCT02522104` - Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)	Phase 4
Recruiting	`NCT04688411` - An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease	N/A
Terminated	`NCT03615924` - Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease	Phase 3
Not yet recruiting	`NCT06300723` - Clinical Study of BRL-101 in Severe SCD	N/A
Recruiting	`NCT03937817` - Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Completed	`NCT04917783` - Health Literacy - Neurocognitive Screening in Pediatric SCD	N/A
Completed	`NCT04134299` - To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease	N/A
Completed	`NCT02580565` - Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide and Analgesics in the Sickle-cell Disease
Recruiting	`NCT04754711` - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition	N/A
Completed	`NCT04388241` - Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD	N/A
Recruiting	`NCT05431088` - A Phase 2/3 Study in Adult and Pediatric Participants With SCD	Phase 2/Phase 3
Completed	`NCT01158794` - Genes Influencing Iron Overload State
Recruiting	`NCT03027258` - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome	N/A
Withdrawn	`NCT02960503` - Macrolide Therapy to Improve Forced Expiratory Volume in 1 Second in Adults With Sickle Cell Disease	Phase 1/Phase 2
Not yet recruiting	`NCT02525107` - Prevention of Vaso-occlusive Painful Crisis by Using Omega-3 Fatty Acid Supplements	Phase 3
Withdrawn	`NCT02630394` - A Pilot Study of Azithromycin Prophylaxis for Acute Chest Syndrome in Sickle Cell Disease	Phase 1
Completed	`NCT02620488` - A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease	N/A