ICH GCP - EU Clinical trials Registry

EudraCT Number: 2004-000326-70

Sponsor Protocol Number: R076477-SCH-302/702

Start Date: 2004-08-11

Sponsor Name: Janssen-Cilag, Johnson & Johnson spol. s.r.o.

Full Title: A Randomized, 6-Week Double-Blind, Placebo-Controlled Study With an Optional 24-Week Open-Label Extension to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliper...

Medical condition: Schizophrenia

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Elderly

Gender: Male, Female

Trial protocol: CZ (Completed)

Trial results: View results

EudraCT Number: 2004-000327-15

Sponsor Protocol Number: XL119-001

Start Date: 2004-11-25

Sponsor Name: Exelixis, Inc.

Full Title: A Phase 3 Multicenter, Single-Blind, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) plus Leucovorin (LV) in Subjects with Advanced Bilary Tumors Not Amenable to Coventional Surgery

Medical condition: Advanced Bilary Tract Tumours: Gall bladder cancer and Cholangiocarcinoma

Disease:	Version	SOC Term	Classification Code	Term	Level
	7.0		10028982		LLT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: ES (Ongoing) GB (Prematurely Ended) BE (Completed) IT (Prematurely Ended)

Trial results: View results

EudraCT Number: 2004-001117-34

Sponsor Protocol Number: APL-B-013-02

Start Date: 2004-10-13

Sponsor Name: Pharma Mar S.A.

Full Title: A Phase II Multicenter,Open-Label, Clinical And Pharmacokinetic Study Of Aplidin® As A 1-Hour Weekly IV Infusion, In Patients With Relapsed Or Refractory aggressive non-Hodgkin’s Lymphoma.

Medical condition: Aggressive non-Hodgkin’s Lymphoma.For aggressive NHL patient cure is still the target of therapy and a CR is a prerequisite to achieve this goal. Salvage therapy needs more aggressive experimental ...

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: ES (Ongoing) IT (Completed)

Trial results: View results

EudraCT Number: 2004-001125-20

Sponsor Protocol Number: FIRM-ACT

Start Date: 2004-07-26

Sponsor Name: AZIENDA OSPEDALIERA S. LUIGI GONZAGA

Full Title: First International Randomized trial in Metastatic Adrenocortical Cancer Treatment FIRM-ACT Etoposide, Doxorubicin, Cisplatin and Mitotane vs. Streptozotocin and Mitotane

Medical condition: Chemotherapy in patients with locally advanced or metastatic adrenocortical cancer in adults and children

Disease:	Version	SOC Term	Classification Code	Term	Level
	6.1		10001378		HLT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: IT (Completed)

Trial results: (No results available)

EudraCT Number: 2004-001823-39

Sponsor Protocol Number: 103502

Start Date: 2004-11-15

Sponsor Name: GlaxoSmithKline Biologicals

Full Title: An open, randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly...

Medical condition: Prophylactic vaccination against pneumococcal diseases in infants and diseases caused by Neisseria meningitidis C.

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Infants and toddlers, Under 18

Gender: Male, Female

Trial protocol: SE (Completed)

Trial results: View results

EudraCT Number: 2004-000751-42

Sponsor Protocol Number: D1441C00150

Start Date: 2006-04-07

Sponsor Name: AstraZeneca AB

Full Title: A 26-week, International, Multicenter, Open-label Phase IIIb Study of the Safety and Tolerability of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in Daily Doses of 400 mg to 800 mg in ...

Medical condition: SCHIZOPHRENIA or BIPOLAR I DISORDER

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Children, Adolescents, Under 18

Gender: Male, Female

Trial protocol: DE (Completed)

Trial results: View results

EudraCT Number: 2004-000773-60

Sponsor Protocol Number: SNMC 301

Start Date: 2004-10-22

Sponsor Name: Healthcare & Pharma Consulting AG (Europe)

Full Title: 52 week multicenter, randomized, double-blind placebo-controlled trial evaluating the efficacy and safety of SNMC in patients with chronic hepatitis C

Medical condition: Chronic hepatitis C

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Adults

Gender: Male, Female

Trial protocol: LV (Completed)

Trial results: (No results available)

EudraCT Number: 2004-000632-82

Sponsor Protocol Number: AC-052-333

Start Date: 2004-09-16

Sponsor Name: Actelion Pharmaceuticals Ltd.

Full Title: Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers

Medical condition: SSc is a multi-system disorder of unknown etiology characterized by fibrosis and vascular obliteration in the skin and visceral organs. The pathogenesis of SSc involves immunologic mechanisms vascu...

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: GB (Completed) IT (Completed)

Trial results: View results

EudraCT Number: 2004-002802-31

Sponsor Protocol Number: PENT-IBD-CH CZ

Start Date: 2005-01-25

Sponsor Name: Ferring-Leciva, a.s.

Full Title: Multicentre, Controlled, Randomised, Open, Cross-over Study Comparing the Acceptability of Pentasa® Sachets versus Pentasa® tbl. 500mg in Children with Crohn´s Disease

Medical condition: children patients with the Crohn s disease in any stage (where mesalazine treatment is appropriate)

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Children, Adolescents, Under 18

Gender: Male, Female

Trial protocol: CZ (Ongoing)

Trial results: View results

EudraCT Number: 2004-002803-34

Sponsor Protocol Number: Cetcapox-RT_31.08.2004

Start Date: 2004-12-23

Sponsor Name: Klinik und Poliklinik fuer Strahlentherapie, Universität Erlangen-Nürnberg

Full Title: Phase I/II-Studie Praeoperative Radiochemotherapie mit Capecitabin plus Oxaliplatin und Cetuximab beim lokal fortgeschrittenen Rektumkarzinom im UICC-Stadium II und III

Medical condition: Rektumkarzinom

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: DE (Completed)

Trial results: (No results available)