DDrare: Database of Drug Development for Rare Diseases

Searched query = "Polycystic kidney disease", "PKD", "PCKD", "Polycystic kidney", "ADPKD", "ARPKD"
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 = 15 or 45 mg; 30 or 60 mg; 30 or 90 mg; AL; AMIAS; AMLODIPINE; APRINOX; Acetate; Amias; Aminohippurate; Aminohippurate Sodium Inj 20%; Amlodipine; Anti-hypertensive medications; Antihypertensive drugs; Aprinox; Arginine; BARDOXOLONE METHYL; BENDROFLUMETHIAZIDE; BIM 23014; BISOPROLOL; BOSUTINIB; Bardoxolone; Bardoxolone Methyl; Bardoxolone methyl; Bardoxolone methyl 10 mg; Bardoxolone methyl 15 mg; Bardoxolone methyl 20 mg; Bardoxolone methyl 5 mg; Bardoxolone methyl capsules; Bardoxolone methyl oral capsule; Behavioral: Diet and water adjustment; Bendroflumethiazide; Bisoprolol; Bosutinib; Bosutinib (anhydrous); C03XA01; CANDESARTAN; CARDURA; Calcineurin inhibitors maintenance; Candesartan; Candesartan and Cilnidipine; Candesartan plus non-CCB agents; Certican; Certican Tabletten; Cilnidipine; Conventional therapy; Curcumin; DOXAZOSIN; Doxazosin; Emodin; Equal; Everolimus; G1117337; GENZ-682452; GLPG2737; GZ402671; Genz-682452-AU; HCT; High water intake; Hydralazine; Hydrochlorothiazide; ISTIN; Imidapril; Intravenous injection autologous mesenchymal stem cells; Iohexol; Iohexol Inj 300 milligrams per milliliter (MG/ML); Istin; JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG); JINARC - 15 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE; JINARC - 30 MG + 60 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 60 MG); JINARC - 30 MG +90 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 90 MG); JINARC - 30 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE; Jinarc; Jinarc - Tolvaptan tablets; Jinarc 15 mg tablets, Jinarc 45 mg tablets; Jinarc 30 mg tablets, 90 mg tablets; Jinarc 30 mg tablets, Jinarc 60 mg tablets; Jinarc® 15mg Tablet; Jinarc® 30 Tablet; KD019 (tesevatinib); LANREOTIDE ACETATE; LISINOPRIL; Lanreotide; Lisinopril; Lixivaptan; Long-acting somatostatin; Losartan; METFORMIN; METFORMINA; MONOCOR; Metformin; Metformina; Monocor; NG-Monomethyl-L-arginine; Ng-monomethyl-L-arginine (drug); Niacinamide; OPC-41061; OPC-41061 (tolvaptan); Octeotride; Octreotide; Octreotide LAR; Octreotide-LAR; Other: Ad libitum water intake; Other: High Water Intake; Other: Low Blood Pressure Control; Other: Saline solution; Other: Saline solution.; Other: Standard; Other: Standard Blood Pressure Control; Other: Water; Other: Water prescription; Other: water; PF-05208763; Pasireotide; Pasireotide LAR; Pioglitazone; Placebo; Potassium; Pravastatin; Procedure: renal sympathetic denervation; Protein; RAD001; RAPAMUNE*100CPR RIV 1MG; RAPAMUNE*30CPR RIV 1MG; RAPAMUNE*30CPR RIV 2MG; RGLS4326; RTA 402; Radiation: PET/CT Scan; Ramipril; Rapamune; Rapamune 1mg tablets; Rapamycin; SANDOSTATINA - LAR 20 MG/2.5 ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE FLACONE POLVERE + SIRINGA PRERIEMPITA 2.5 ML + 2 AGHI; SANDOSTATINA LAR; SAR402671, GZ402671 or GZ/SAR402671; SIROLIMUS; SKI-606; Saline; Samsca; Samsca 15 mg tablets; Samsca 30 mg tablets; Sandostatin LAR; Sandostatina; Sandostatina LAR; Sandostatina Lar IM Fl 20mg +2F; Sirolimus; Sodium citrate; Sodiumchloride; Somatostatin; Somatuline; Somatuline Autogel; Somatuline Autosolution; Spironolactone; Sugar pill; TOLVAPTAN; TOLVAPTAN (OPC-41061); TOLVAPTAN 15; TOLVAPTAN 30; TOLVAPTAN 45/15; TOLVAPTAN 60/30; Telmisartan; Tesevatinib; Tetracosactin; Tolvaptan; Tolvaptan (OPC-41061); Tolvaptan 15 mg Tablet; Tolvaptan 15 mg tablets; Tolvaptan 15mg; Tolvaptan 30 mg Tablet; Tolvaptan 30 mg tablets; Tolvaptan 30mg; Tolvaptan 7.5 mg Tablet; Tolvaptan IR; Tolvaptan MR; Tripterygium; Tripterygium Wilfordii; Tripterygium wilfordii; Triptolide; Triptolide-Containing Formulation; UDCA; URSOCHOL 300; Unknown; Ursochol; Ursodeoxycholic Acid; Ursodeoxycholic acid; Venglustat; Venglustat GZ/SAR402671; Venglustat GZ402671; Water; ZESTRIL; ZUGLIMET - 500 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE IN BLISTER PVC/AL; [METFORMINA]; [TOL; [TOLVAPTAN 15]; [TOLVAPTAN 30]; [TOLVAPTAN 45/15]

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	EUCTR2010-023017-65-BG (EUCTR)	14/05/2012	22/05/2012	A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden
2	EUCTR2010-023017-65-LT (EUCTR)	14/11/2011	02/09/2011	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden
3	EUCTR2010-023017-65-CZ (EUCTR)	16/06/2011	01/02/2011	A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 2	United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Japan;Moldova, Republic of;Sweden
4	EUCTR2010-023017-65-HU (EUCTR)	27/05/2011	05/04/2011	A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 2	United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Germany;Japan;Moldova, Republic of;Sweden
5	EUCTR2010-023017-65-SK (EUCTR)	25/05/2011	28/04/2011	A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 2	United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden
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
6	EUCTR2010-023017-65-PL (EUCTR)	21/04/2011	12/04/2011	A multicenter, randomized, double-blind, placebo-controlled study of thesafety, effectiveness, and pharmacokinetics of bosutinib versus placebo insubjects with polycystic kidney disease	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	Hungary;Czech Republic;Slovakia;Spain;Poland;Lithuania;Italy;United Kingdom;Sweden
7	EUCTR2010-023017-65-ES (EUCTR)	18/03/2011	27/01/2011	ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD).	ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD).	Poliquistosis renal autosómica dominante (PRAD). MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	PFIZER, S.L.U.	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden
8	EUCTR2010-023017-65-SE (EUCTR)	17/03/2011	20/01/2011	A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)	Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 2	United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden

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

EUCTR2010-023017-65-BG
(EUCTR)

14/05/2012

22/05/2012

A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2

United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden

EUCTR2010-023017-65-LT
(EUCTR)

14/11/2011

02/09/2011

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2

Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden

EUCTR2010-023017-65-CZ
(EUCTR)

16/06/2011

01/02/2011

A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2

United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Japan;Moldova, Republic of;Sweden

EUCTR2010-023017-65-HU
(EUCTR)

27/05/2011

05/04/2011

A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2

United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Germany;Japan;Moldova, Republic of;Sweden

EUCTR2010-023017-65-SK
(EUCTR)

25/05/2011

28/04/2011

A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2

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

EUCTR2010-023017-65-PL
(EUCTR)

21/04/2011

12/04/2011

A multicenter, randomized, double-blind, placebo-controlled study of thesafety, effectiveness, and pharmacokinetics of bosutinib versus placebo insubjects with polycystic kidney disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2

Hungary;Czech Republic;Slovakia;Spain;Poland;Lithuania;Italy;United Kingdom;Sweden

EUCTR2010-023017-65-ES
(EUCTR)

18/03/2011

27/01/2011

ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD).

Poliquistosis renal autosómica dominante (PRAD).
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

PFIZER, S.L.U.

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2

Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden

EUCTR2010-023017-65-SE
(EUCTR)

17/03/2011

20/01/2011

A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2