DDrare: Database of Drug Development for Rare Diseases

Searched query = "Single Ventricle", "SV", "Single ventricle heart defect", "Univentricular heart", "UVH", "Single ventricular circulation syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = ACETYLSALICYLIC ACID; ACT-064992; Acetylsalicylic acid; Administration of an ACE-inhibitor or not; Aesculus Hippocastanum / Horse Chestnut; Ambrisentan; Arginine; Aspirin; Autologous Tissue-Engineered Vascular Graft; BAY 59-7939; Bosentan; Carvedilol; Colchicine; Digoxin; Enalapril; Eplerenone; Horse chestnut; JNJ-39039039; Liothyronine; Liothyronine I 131; MACITENTAN; MPC; MZ101; Macitentan; Milk; Mysildecard; Mysildecard 20 mg; Nitric Oxide; Normal Saline; ODSH at 0.125 mg/kg/h; ODSH at 0.250 mg/kg/h; ODSH at 0.375 mg/kg/h; Opsumit; Opsumit®; Other: Human Milk Derived Fortifier; Other: Human/Bovine Milk; RIVAROXABAN; Rexlemestrocel-L; Rivaroxaban; SCRM001_TEVG; Sildenafil; Sildenafil by injection; Spironolactone; Spironolactone (drug); Sugar pill; Tadalafil; Tadalafil Citrate; Tracleer; Treprostinil; Udenafil; Vasopressin; Vasopressin, Arginine; Vitamin C; Xarelto

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03997097 (ClinicalTrials.gov)	February 1, 2021	18/6/2019	Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease	Phosphodiesterase-type 5 Inhibitors in Adult and Adolescent Patients With Univentricular Heart Disease: a Multi-center, Randomized, Double Blind Phase III Study	Single-ventricle;Pulmonary Hypertension;Univentricular Heart	Drug: Sildenafil;Drug: Placebos	University Hospital, Montpellier	NULL	Not yet recruiting	15 Years	80 Years	All	50	Phase 3	NULL
2	NCT01169519 (ClinicalTrials.gov)	April 2011	7/7/2010	Sildenafil in Single Ventricle Patients	Safety, Pharmacokinetics and Hemodynamic Efficacy of Sildenafil in Single Ventricle Patients	Heart Disease	Drug: Sildenafil by injection	Duke University	NULL	Completed	3 Months	120 Months	All	21	Phase 1	United States
3	JPRN-UMIN000005343	2011/01/01	01/04/2011	Effect of sildenafil in patients with single ventricle physiology		Single ventricle physiology	Administration of sildenafil	Tokyo Women's Medical University	NULL	Recruiting	3months-old	Not applicable	Male and Female	30	Not applicable	Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03997097
(ClinicalTrials.gov)

February 1, 2021

18/6/2019

Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease

Phosphodiesterase-type 5 Inhibitors in Adult and Adolescent Patients With Univentricular Heart Disease: a Multi-center, Randomized, Double Blind Phase III Study

Single-ventricle;Pulmonary Hypertension;Univentricular Heart

Drug: Sildenafil;Drug: Placebos

University Hospital, Montpellier

NULL

Not yet recruiting

15 Years

80 Years

All

Phase 3

NULL

NCT01169519
(ClinicalTrials.gov)

April 2011

7/7/2010

Sildenafil in Single Ventricle Patients

Safety, Pharmacokinetics and Hemodynamic Efficacy of Sildenafil in Single Ventricle Patients

Heart Disease

Drug: Sildenafil by injection

Duke University

NULL

Completed

3 Months

120 Months

All

Phase 1

United States

JPRN-UMIN000005343

2011/01/01

01/04/2011

Effect of sildenafil in patients with single ventricle physiology

Single ventricle physiology

Administration of sildenafil

Tokyo Women's Medical University

NULL

Recruiting

3months-old

Not applicable

Male and Female

Not applicable

Japan