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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: |
EUCTR2007-001125-97-ES |
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Date of registration:
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03/12/2007 |
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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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Eficacia y Seguridad de Losartán vs Atenolol en la prevención de la dilatación progresiva de la aorta en la población de pacientes con Síndrome de Marfan (Losartan vs atenolol efficacy and security in aortic dilatation prevention in Marfan syndrome)
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Scientific title:
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Eficacia y Seguridad de Losartán vs Atenolol en la prevención de la dilatación progresiva de la aorta en la población de pacientes con Síndrome de Marfan (Losartan vs atenolol efficacy and security in aortic dilatation prevention in Marfan syndrome) |
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Date of first enrolment:
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20/05/2008 |
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Target sample size:
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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:2007-001125-97 |
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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: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Spain
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Marfan syndrome patients between 7 and 60 years old.
Are the trial subjects under 18? yes
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) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
a) Pregnancy or lactancy; b) Patients enrolled in other clinical trial; c) Previous cardiac or aortic surgery; d) Previous aortic disection ; e) Moderate or severe valvulopathy; f). Status NYHA III- IV; g) Respiratory, hepatic (ALT>3xLNS) or renal(creat < 30 ml/min) failure, or any other illness which modify the evaluation of the treatment.h) High hipersensibility, intolerance or contraindication to the treatment.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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The aortic dilatation in Marfan syndrome with two different treatments: losartan vs atenolol
MedDRA version: 9.1
Level: LLT
Classification code 10026829
Term: Marfan's syndrome
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Intervention(s)
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Trade Name: cozaar 50
Pharmaceutical Form: Capsule*
INN or Proposed INN: LOSARTAN POTASSIUM
CAS Number: 124750998
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: blokium 50
Pharmaceutical Form: Capsule*
INN or Proposed INN: ATENOLOL
CAS Number: 29122687
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: COZAAR INICIO 12,5 mg comprimidos recubiertos con pelicula
Pharmaceutical Form: Capsule*
INN or Proposed INN: LOSARTAN POTASSIUM
CAS Number: 124750998
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: BLOKIUM 50 mg comprimidos
Pharmaceutical Form: Capsule*
INN or Proposed INN: ATENOLOL
CAS Number: 29122687
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
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Primary Outcome(s)
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Secondary Objective: Variations in elastic properties of the aortic wall.
Incidence of clinical aspects: aortic disection, aortic rupture, aortic operation or death.
Validation of the dose and efficacy of losartan.
Modificacion of dural ectasia
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Main Objective: evaluate the role of losartan vs atenolol in the prevention of aortic dilatation in patients with marfan syndrome
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Primary end point(s): Main variable assessed is the progression of aortic dilatation and one of the secondary variables is elasticity changes in the aorta wall in patients treated by losartan vs atenolol during 3 years of follow-up. Aorta dilatation was choosen as the main variable since it is related to dissection and aortic rupture.
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Secondary ID(s)
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LO-AT-MARFAN
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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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