Leriche-Fontaine stage II PAD presenting symptoms of intermittent claudication MedDRA version: 9.1 Level: LLT Classification code 10013283 Term: Disorder vascular peripheral
Conditions
Interventions
Product Name: betaine
Pharmaceutical Form: Oral powder
INN or Proposed INN: betaine
CAS Number: 107-43-7
Concentration unit: % percent
Concentration type: equal
Concentration number: 99.8-
Pharmaceuti
Sponsors
VAS VASCULAR INDEPENDENT RESEACH AND EDUCATION EUROPEAN ORGANIZATION. C/O UNIV MILANO. OSP. L. SACCO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female subjects with Leriche-Fontaine stage II PAD presenting symptoms of intermittent claudication for at least 6 months. 2) Age between 50 and 80 years. 3) Objective evidence confirming the clinical diagnosis of PAD (ankle/brachial index 50 m in the standardized treadmill testing. 5) Clinical stability before inclusion (i.e. changes in ACD not exceeding 25 % in two standardized treadmill testings during run-in). 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
Exclusion criteria: 1. Unstable symptoms and/or rapid deterioration of PAD during the previous 3 months. 2. Presence of clinically significant renal or hepatic insufficiency, or insulin-dependent type 1 diabetes. 3. Uncontrolled type 2 diabetes, arterial hypertension or dyslipidemia 4. Any clinical conditions limiting the subject?s ability to exercise (angina pectoris, congestive heart failure, respiratory disease, orthopaedic disease, neurological disorders). 5. Subjects with high variability in walking distance (treadmill testing performed at interval ≥ 1 week; maximum change in absolute claudication distance < 25%). 6. Active peptic ulcer disease during the previous 6 months. 7. Any haemorrhagic condition or history of bleeding. 8. Acute coronary syndrome or acute cerebrovascular episodes during the previous 6 months. 9. Previous revascularisation procedures or PTA during the last 6 months or indication for vascular surgery. 10. Ischemic rest pain or gangrene. 11. Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. 12. History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g. bronchospasm, or hypotension). 13. Known history of cystathionine beta-synthase (CBS) deficiency. 14. Known or suspected alcohol, drug or medication abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the best dosage of Betaine to be used in PAD (Peripheral Arterial Occlusive Disease) in regard of clinical parameters.;Secondary Objective: Secondary objectives are to select concentration dependent parameters which may be responsible of the MoA and to evaluate the safety of the product Evaluation of the product safety profile;Primary end point(s): To evaluate the best dosage of Betaine to be used in the clinical treatment of subjects affected by PAD according to a dose-response study model. | — |
Countries
Italy, Slovenia
Outcome results
None listed