None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Niaspan, in tablets, at a dose of 500 mg, PO, QD + Niaspan Placebo, at a dose of 1000 mg, PO, QD during weeks 1 and 2. For weeks 3 and 4, the dose of Niaspan will be increased to 1000 mg, PO, QD and the dose of Niaspan Placebo will be reduced 500 mg, PO, QD. For weeks 5 -12, the Niaspan dose will be increased to 2000 mg, PO, QD and the Niaspan Placebo will be discontinued. Acetylsalicylic Acid, at a dose of 325 mg, PO, QD, will be administered concomitantly during
This group will be treated with Niaspan, in tablets, at a dose of 100 mg, PO, QD + Niaspan Placebo, at a dose of 500 mg, PO, QD during weeks 1 to 4. For weeks 5 -12, the Dosage of Niaspan will be increased to 2000 mg, PO, QD and the Niaspan Placebo will be discontinued. Acetylsalicylic Acid, at a dose of 325 mg, PO, QD, will be administered concomitantly during these 12 weeks. Once these 12 weeks are over, the group will be divided into 2 branches:
Branch A: This subgroup will be treated with
Sponsors
KENDLE PERU S.R.L,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, 21 years of age or older. 2. Can read and understand, and is willing and able to sign a written informed consent form. 3. If the patient is a woman with gestation potential: a) She must not be pregnant or breastfeeding. b) Do not plan a pregnancy or have the intention to breastfeed. c) Commit to use oral contraceptives, intrauterine device (IUD) or a double barrier contraceptive method, for the duration of the study. d) If oral contraceptives are being used, it must have been done for at least 3 months before the random grouping, and continue doing so for the duration of the study. 4. Fasting laboratory values during the Screening Visit, as indicated below: a) HDL-C 150 mg / dL, but 100 mg / dL, but <250 mg / dL.
Exclusion criteria
Exclusion criteria: 1. Has taken, within the last 3 months, a product containing niacin in doses> 30 mg and can not commit to refrain from the use of such products for the duration of the study. 2. It has suspended the previous use of Niaspan in therapeutic doses, due to the intolerance of the symptoms of flushing. 3. Hypersensitive and / or allergic to niacin, ASA, NSAIDs, or any other component of these medications. 4. Currently under an AAS regimen of daily dose> 81 mg. 5. Currently under an AAS regimen of 81 mg daily dose, for CV protection and can not commit to adjusting the daily dosing time to allow at least 10 hours between dosing the study medication and the daily dose of the regimen. AAS 6. Taking some other product that contains AAS and can not commit to abstain. 7. Taking NSAIDs for any reason and can not commit to abstaining. 8. Taking statins, or other lipid-modifying medication, for which the dose has not been stable for at least 4 weeks before the Screening Visit and can not be maintained for the duration of the study. 9. Taking a medication that has slight effects on serum lipid levels, for which the dose has not been stable for at least 4 weeks before the Screening Visit and may be significantly altered during participation in the study. 10. Taking some oral or systemic medication from the class of steroids. 11. Level of glycosylated hemoglobin (HbA1c)> 8.0%. 12. Has a nephrotic syndrome, dysproteinemia, or severe kidney failure. 13. Has active peptic ulcer disease. 14. Has a history of gastrointestinal (GI) bleeding associated with ASA. 15. Have had unstable angina or acute myocardial infarction in the previous 3 months. 16. Has active gout. 17. Has vitamin K deficiency, hemophilia, or tendency to bleeding problems. 18. Has a predisposition to arterial bleeding. 19. Has asthma syndrome, rhinitis, and nasal polyps. 20. Is a carrier of the human immunodeficiency virus (HIV). 21. Has active hepatitis, obstructive liver disease, or alanine aminotransferase and aspartate aminotransferase levels ≥ 1.3 times higher than the upper limit of normal (ULN). 22. Has underlying flushing syndrome or other dermatological disorders. 23. Consume, on average, more than two alcoholic beverages per day or have a prior history of substance abuse or dependence. 24. Used a medication from a research study or participated in a study of a drug under investigation 30 days before. 25. Unable to properly complete the record of information in the Electronic Journal of Rubefaccion for any reason. 26. Has a medical condition or laboratory abnormality, which may be adversely affected by the procedures or medications in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Visual analog scale (EVA) of 100 mm. Measure:Average intensity of the flushing events. Timepoints:Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1 to 6: All these criteria will be extracted from the data of the Electronic Journal of Rubefaccion, prepared by the patients. In this diary, an EVA scale and a Liekert scale (mild, moderate or severe) will be used to evaluate the severity of the flushing events. In addition the days in which there were and there were no episodes of redness will be written down. Criterion 7: Peripheral blood levels of total cholesterol [TC], HDL-C, non-HDL-C, LDL-C, TG, lipoprotein a, and the proportion of LDL-C: HDL-C. Measure:Secondary efficacy: 1) Number of days in the week in which moderate / severe flushing occurs. 2) Average number of episodes of flushing per day per subject. 3) Average duration of the flushing episodes. 4) Number of days a week without episodes of flushing. 5) Average intensity of redness episodes. 6) Number of days without reddening from Week 13 to 16. 7) Percentage change from the baseline for lipid parameters. Timepoints:Criteria 1, 2, 3, 4 and 6: Week 12. Criterion 5: Weeks 13 to 16. Criterion 7: Weeks 8 and 16. ; Outcome name:Criterion 1: Clinical evaluation of any unwanted medical event in a patient to whom the investigational product was administered. Criterion 2: Panels of hematology, coagulation and serum chemistry. Criterion 3: Evaluation of heart rate and systolic and diagnostic blood pressure while sitting (after 10 minutes of rest). Criterion 4: Standard full physical examination. Measure:Security: 1) Adverse events (EA). 2) Clinical laboratory parameters. 3) Vital signs. 4) Results of the physical examination. Timepoints:Criteria 1, 3 and 5: Days 0, 14, 28, 56, 84 and 112. Criterion 2: Days 28 and 56 | — |
Countries
Argentina, Paraguar, United States
Outcome results
None listed