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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2005-002900-40-IT
Date of registration:	17/01/2007
Prospective Registration:	No
Primary sponsor:	ACTELION PHARMACEUTICALS ITALIA
Public title:	LONG-TERM OPEN-LABEL STUDY IN PATIENTS WITH INOPERABLE CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION CTEPH WHO COMPLETED THE PROTOCOL AC-052-366/BENEFIT.
Scientific title:	LONG-TERM OPEN-LABEL STUDY IN PATIENTS WITH INOPERABLE CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION CTEPH WHO COMPLETED THE PROTOCOL AC-052-366/BENEFIT.
Date of first enrolment:	23/01/2006
Target sample size:	128
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002900-40
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Continuazione in aperto dello studio BENEFIT If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Czech Republic	Germany	Italy	Spain	United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Treatment of inoperable chronic thronboembolic pulmonary hypertension.
MedDRA version: 6.1 Level: PT Classification code 10037400

Intervention(s)

Trade Name: TRACLEER*56CPR RIV 125MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Bosentan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-

Primary Outcome(s)

Secondary Objective:

Main Objective:

Primary end point(s):

Secondary Outcome(s)

Secondary ID(s)

AC-052-370

2005-002900-40-ES

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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