Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT01145612
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must conform to the diagnostic criteria Marfan syndrome according to the Ghent Criteria.
2. Outpatient subjects.
3. Male or female, aged between 5 and 60 years.
4. Women who are in a childbearing age are required a result of negative Gonadotropin pregnancy test to be included in the study.
5. Subjects must be able to take oral medication.
6. After having received information about the study, subjects must understand the nature of it and give written informed consent.
7. For Subjects under 18 years, the informed consent must be signed by their parents or guardians.
8. Subjects with a maximum diameter of the aorta, at length, \<45 mm
9. Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and three months after the last dose study medication.
For the purposes of this study, women of childbearing potential is defined as: All female subjects after puberty unless they are post-menopausal for at least two years, or are surgically sterile. Adequate contraception is defined as two barrier methods, or one barrier method with a spermicide, or an intrauterine device or use of the oral female contraceptive (or other hormonal methods).
Exclusion Criteria:
1. Women who are pregnant, suspected to be pregnant or breast-feeding.
2. Ongoing participation in another clinical trial or who received the investigational drug in the month prior to the inclusion in the study.
3. Known or suspected failure to comply with the study protocol.
4. Previous surgery: cardiac or at any segment of the aorta.
5. Functional class III-IV.
6. Maximum diameter of the aorta exceeding 45 mm
7. More than moderate valvular involvement.
8. History or presence of respiratory failure, liver (ALT\> 3 x ULN), renal (creatinine clearance \<30 mL / min), gastrointestinal, hematological, endocrine, or any other situation that may affect the assessment of the study treatment, according to the investigator opinion.
9. History of aortic dissection.
10. History or presence of neurological disease (especially seizures, dementia ...).
11. History or presence of alcohol abuse and / or toxic substances
12. Uncontrolled depression.
13. Any need for another antihypertensive treatment (betablockers, diuretics, calcium channel blockers, ACE inhibitors, ARBs, etc.)
14. Hypersensitivity, intolerance or contraindication to any component of the study drug.
15. Patients with a history of drug abuse or toxic dependence.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
60 Years
Study:
NCT01145612
Study Brief:
Protocol Section:
NCT01145612