None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Niacin Placebo, PO, QD for 2 weeks. After this period, treatment will begin with MK-0524 A. Beginning with a dose of 1 g, PO, QD, and will be increased to 2 g in 4 weeks, maintaining this dose until completing 16 weeks of treatment.
Group name:GROUP 2 Type of group
This group will be treated with Niacin Placebo, PO, QD for 2 weeks. After this period, treatment with Niacin extended release (E-R) will begin. Starting with a dose of 0.5 g, PO, QD, that will be increased 0.5 g every 4 weeks, until reaching the final dose of 2 g. which will be maintained until completing 16 weeks of treatment.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Application of the GFSS, with a result ≥ 4. Measure:Number of days per week with Global Flushing Severity Scale (GFSS) moderate or major during the treatment period. Timepoints:During the 16 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Application of the GFSS, with a result ≥ 4. Measure:1) Number of days per week with moderate or higher GFSS during weeks 1, 5, 9 and 13 combined. 2) Number of days per week with moderate or higher GFSS during weeks 2-16. Timepoints:1) Weeks 1, 5, 9 and 13. 2) Weeks 2-16. ; Outcome name:Lipid profile: LDL-C, HDL-C, not HDL-C, TG and TC. GFSS: Where, None or mild <4, Moderate or greater ≥ 4, severe or extreme ≥ 7. Discontinuation due to flushing: Yes / No. Measure:1) Percent change from the baseline in the lipid profile. 2) Days per week with severe or extreme GFSS. 3) Average GFSS during treatment. 4) Discontinuation due to flushing. 5) Maximum GFSS 6) Maximum GFSS like none / mild, moderate, severe or extreme. 7) Percentage of patients with severe or extreme maximum GFSS during treatment. Timepoints:1) Lipid profile: Week 16. 2) Days with severe or extreme GFSS, maximum GFSS: Weeks 1, 5, 9 and 13. 3) Average GFSS, Percentage of patients with severe or extreme maximum GFSS: During the 16 weeks of treatment. 4) Discontinuation due to flushing: When the event occurs. ; Outcome name:Global Score of Disruptions Caused by Rubefaction (GFBS). Individual symptom score: Evaluation of pruritus, tingling, heat and redness. Duration of episodes of flushing, Days with difficulty sleeping, Days of NSAID use: Journal of patients. Questionnaire on the Impact of Redness. Measure:8) Days per week with GFBS. 9) Days per week with individual or moderate symptom scores. 10) Average duration of flushing episodes. 11) Days per week with difficulty sleeping. 12) Scoring of the Questionnaire on the Impact of Redness. 13) Number of days per week where NSAIDs were used. Timepoints:1) Days with GFBS: Weeks 1, 5, 9 and 13. 2) Days with moderate or greater individual symptoms, Duration of episodes of flushing, Days with use of NSAIDS: When the event occurs. 3) Questionnaire on the Imp | — |
Countries
Australia, Canada, Chile, Colombia, Israel, Mexico, New Zealand, Switzerland, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed