Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)
- Conditions
- -R232 FlushingFlushingR232
- Registration Number
- PER-074-06
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. The patient is male or female ≥ 18 and ≤ 80 years old on the day they sign the informed consent.
2. The patient understands the study procedures, alternative treatments available and the risks involved in the study and agrees to voluntarily participate by giving written informed consent.
3. Contraception for female patients of childbearing age: A patient of childbearing age agrees to abstain or use 2 acceptable methods of birth control during the course of the study.
4. The patient is an appropriate candidate for niacin therapy.
5. Patient has TG <500 mg / dL (5.65 mmol / L) at Visit 1 or within 6 months prior to Visit 1.
6. The patient s glycemic condition has been determined before Visit 2.
1. The patient is pregnant or breastfeeding, or waiting to conceive during the study, including the 14-day follow-up after the study.
2. The patient has a history of malignancy <5 years before signing the informed consent.
3. The patient is waiting to donate eggs during the study, including the 14-day follow-up.
4. The patient has a history or current evidence of any condition, therapy or abnormality of the laboratory tests that could confuse the results of the study, interfere with the participation of the patient during the entire course of the study, or not be the most convenient for the patient to participate.
5. The patient consumes more than 2 alcoholic drinks per day.
6. It is unlikely that the patient sticks to the study procedures, respects appointments or is planning to move during the study.
7. The patient is participating, currently or has participated in a study with: a) A compound under investigation within 30 days prior to Visit 1. b) A lipid modifying compound within 8 weeks prior to the Visit one.
8. The patient has donated and / or received blood.
9. The patient has the following excluding values: a) Creatinine> 2.0 mg / dL. b) ALT (SGPT)> 1.5 x ULN. c) AST (SG0T)> 1.5 x ULN. d) CK> 2 x ULN.
10. The patient is a user of recreational or illicit drugs or has had a recent history of alcohol or drug abuse.
11. The patient is currently experiencing hot flushes due to menopause.
12. The patient is currently involved, or plans to become involved during the study, in vigorous exercise or an aggressive diet regimen.
13. The patient has evidence of ischemic cardiovascular disease.
14. The patient has 2 or more risk factors for coronary heart disease.
15. The patient suffers from uncontrolled / unstable cardiac arrhythmias.
16. The patient suffers from chronic heart failure.
17. The patient suffers from Type 1 or Type 2 diabetes mellitus and meets one or more of the following criteria: a) Has poor control. b) The disease has been diagnosed recently. c) The patient has recently experienced repeated hypoglycaemia or unstable glycemic control. d) The patient is receiving new or recently adjusted antidiabetic pharmacotherapy within 3 months prior to the randomization visit. e) The patient has LDL-C ≥ 130 mg / dL (3.37 mmol / L).
18. The patient suffers from an uncontrolled endocrine or metabolic disease known to influence lipids or serum lipoproteins.
19. The patient suffers from nephrotic syndrome or other clinically significant kidney disease.
20. The patient has suffered from active peptic ulcer within 3 months prior to Visit 1.
21. The patient has had a gout episode within the 1 year period prior to Visit 1.
22. The patient has a history of hypersensitivity to niacin or products containing niacin.
23. The patient suffers from uncontrolled hypertension in Visit 1.
24. The patient has a history of ileal bypass, gastric bypass or other significant condition associated with malabsorption.
25. The patient has active or chronic hepatobiliary or hepatic disease.
26. The patient is HIV positive.
27. The patient has initiated therapy with lipid modifying agents within 6 weeks before Visit 1.
28. The patient has begun treatment with orlistat, sibutramine or another anti-obesity medication within 3 months prior to randomization.
29. The patient is currently taking niacin ≥ 50 mg / day.
30. The patient is curre
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Application of the GFSS, with a result ≥ 4.<br>Measure:Number of days per week with Global Flushing Severity Scale (GFSS) moderate or major during the treatment period.<br>Timepoints:During the 16 weeks of treatment.<br>
- Secondary Outcome Measures
Name Time Method