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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. |
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Register:
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EUCTR |
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Last refreshed on:
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16 December 2019 |
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Main ID: |
EUCTR2006-005361-19-GB |
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Date of registration:
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17/12/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of the efficacy of the dual endothelin 1 receptor antagonist Bosentan in the treatment of Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and in the treatment of Pulmonary Hypertension secondary to sarcoidosis
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Scientific title:
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Evaluation of the efficacy of the dual endothelin 1 receptor antagonist Bosentan in the treatment of Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and in the treatment of Pulmonary Hypertension secondary to sarcoidosis |
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Date of first enrolment:
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09/03/2007 |
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Target sample size:
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45 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005361-19 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Any Patient with Chronic Obstructive Pulmonary Disease or Sarcoid with Pulmonary Hypertension. Pulmonary hypertension is defined as a mean pulmonary artery pressure in excess of 20mmHg at rest. Pulmonary hypertension is defined as an elevated mean pulmonary artery pressure of 20 mmHg or greater at rest or 30 mmHg with exercise.
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:
Bosentan is contraindicated in patients with moderate to severe liver dysfunction and therefore this is an exclusion criteria.
There is limited experience with Bosentan in patients with a body weight below 40 kg, although this is not an absolute exclusion criteria this would require more frquent monintoring and is a relative contraindication for inclusion in the trial.
Excessive age is a relative contraindication given the number of clinic visits(>85 years old).
Children Safety and efficacy in patients under the age of 12 years have not been established so this is an exclusion criteria. (Age <12)
Pregnancy is absolute ecxlusion to the trial - therefore females entering the trial of child bearing age would need two forms of contraception and a pregnancy test prior to entry.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and secondary to Sarcoid
Patients devolop pulmonary hypertension for various reasons, two common causes are Chronic Obstructive Pulmonary disease and Sarcoid. Once developed it may go on to cause right heart failure and severe breathlessness and eventually death.
We believe that the use of bosentan may lower the pulmonary hypertension and improve symptoms.
MedDRA version: 8.1
Level: LLT
Classification code 10037400
Term: Pulmonary hypertension
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Intervention(s)
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Trade Name: Tracleer
Product Name: tracleer
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Bosentan monohydrate
CAS Number: 147536978
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 62.5mg-125mg
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Primary Outcome(s)
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Primary end point(s): The primary end points in the trial would to be to review patients before treatment and after 1 year of treatment. The end points studied would be;
1 Survival
2 Pulmonary pressures monitored by Right Heart Catheter.
3 Exercise tolerance - measured by the six minute walk test.
4 Lung function tests
5 Quality of Life assessment
6 Echo appearence of right ventricle and pulmonary pressures
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Secondary Objective: To ensure that Bosentan is a safe and well tolerated treatment in patients with secondary pulmonary hypertension. This would be answered by monitoring patients very carefully whilst on the treatment and reporting any side effects.
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Main Objective: Patients devolop pulmonary hypertension for various reasons, two common causes are Chronic Obstructive Pulmonary disease and Sarcoid. Once developed it may go on to cause right heart failure and severe breathlessness and eventually death.
We believe that the use of bosentan may lower the pulmonary hypertension and improve symptoms. We therefore wish to trial the use of bosenten in patients with secondary pulmonary hypertension and see if after a period of treatment their pulmonary pressure falls, if their lung function improves, if their exercise tolerance improves and if quality of life improve.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
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Results
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Results available:
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Date Completed:
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