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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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19 March 2012 |
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Main ID: |
EUCTR2005-000755-15-GB |
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Date of registration:
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27/05/2005 |
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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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Perhexiline therapy in patients with Hypertrophic Cardiomyopathy
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Scientific title:
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Perhexiline therapy in patients with Hypertrophic Cardiomyopathy |
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Date of first enrolment:
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25/10/2005 |
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Target sample size:
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50 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000755-15 |
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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: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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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:
Symptomatic non-obstructive hypertrophic cardiomyopathy patients with less than 70% of predicted peak Vo2 and in sinus rhythm
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:
Abnormal liver function test, Pre-existing peripheral neuropathy, Concomitant use of amiodarone and women of childbearing potential .
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Hypertrophic Cardiomyopathy
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Intervention(s)
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Product Name: Pexsig
Pharmaceutical Form: Tablet
INN or Proposed INN: Perxexiline
CAS Number: 6724-53-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: Main objective :to test whether perhexiline improve exercise capacity(peakVo2) in patients with HCM.
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Primary end point(s): Peak Vo2
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Secondary Objective: Secondary objectives : symptoms,cardiac and skeletal energitics, exercise cardiac output,diastolic function and ejection fraction.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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