Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America
- Registration Number
- NCT01200160
- Lead Sponsor
- Abbott
- Brief Summary
Post-Marketing Observational study of Niaspan® tablet in accordance with each country regulations. This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the follow-up of subject's is not prescriptive in nature and is according to the judgment of the physician (investigator in the course of treatment for each patient), within the period of observation of 12 months. This includes an enrollment period of 6 months in which each subject will be observed for approximately 6 months. Examinations, diagnostic measures, findings and observations performed as per usual medical practice during the observation period will be recorded on Case Report Forms (CRFs) by the investigator or site staffs according to the protocol.
- Detailed Description
This is a Post-Marketing Observational study (PMOS) of Niaspan® tablet in accordance with each country regulations. This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the follow-up of subject's is not prescriptive in nature and is according to the judgment of the physician (investigator in the course of treatment for each patient), within the period of 12 months. This includes an enrollment period of 6 months and a treatment duration in which each subject will be observed for approximately 6 months. Examinations, diagnostic measures, findings and observations performed as per usual medical practice during the observation period will be recorded on CRFs by the investigator or site staffs according to the protocol.
Prior to enrollment in the study, each subject will be required to give their written informed consent to participate in the study. Written informed consent will include a statement authorizing the use and/or disclosure of their personal and/or health data. The subject will be assured that patient confidentiality will be maintained at all times according to the local regulations, and that data that might identify the patient will not be collected
For patient's consenting to participate in this PMOS study and meeting all of the inclusion and none of the exclusion criteria, at the initial visit or baseline as well at subsequent visits if appropriate , their demographic, medical history, physical examination, vital sign, flushing/adverse event assessments, concomitant medication information, Niaspan dose change/compliance, and lab testing will be documented as per standard medical practice in each country, although not in a protocolized manner.
If Niaspan® treatment is discontinued, subjects will be followed for another 1 month for any adverse event.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lipid abnormalities Niacin Niacin
- Primary Outcome Measures
Name Time Method Effectiveness of Niaspan 24 weeks regarding baseline visit (visit1) Increasing serum HDL-C (high-density lipoprotein - cholesterol) levels.
Calculated change in different variables (Difference percent for HDL, LDL, Non-HDL and Triglycerides) was obtained using the expression:
percent.change=((final.visit.variable-baseline.variable.))/(baseline.variable))\*100 Then percent change is calculated at 24 weeks regarding baseline for different variables.
- Secondary Outcome Measures
Name Time Method Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values every 4 to 8 weeks for 24 weeks Evaluation of changes in non-HDL-C (non-high-density lipoproteins-cholesterol) lipids, LDL- C (low-density lipoproteins-cholesterol), total cholesterol and triglycerides (including in subjects with high triglycerides ≥ 200 mg/dL), and the impact on the Framingham score
Frequency of Flushing Events every 4 weeks for 24 weeks evaluate occurrence of such events over time
Overall Safety and Tolerability of Niaspan every 4 weeks for 24 weeks Evaluate overall safety of Niaspan through evaluation of adverse events
Trial Locations
- Locations (22)
Site Reference ID/Investigator# 42110
🇲🇽Aguascalientes, Mexico
Site Reference ID/Investigator# 42106
🇲🇽Mexico City DF, Mexico
Site Reference ID/Investigator# 42104
🇲🇽Tijuana, Baja California Norte, Mexico
Site Reference ID/Investigator# 44202
🇻🇪Bolivar, Venezuela
Site Reference ID/Investigator# 44206
🇻🇪Caracas, Venezuela
Site Reference ID/Investigator# 48183
🇨🇴Cali, Colombia
Site Reference ID/Investigator# 42105
🇲🇽Metepec, Estado de Mexico, Mexico
Site Reference ID/Investigator# 26348
🇲🇽Mexico D.F., Mexico
Site Reference ID/Investigator# 42111
🇲🇽Tuxtla Gutierrez, Chiapas, Mexico
Site Reference ID/Investigator# 48182
🇨🇴Cali, Colombia
Site Reference ID/Investigator# 42103
🇲🇽Guadalajara, Jalisco, Mexico
Site Reference ID/Investigator# 42102
🇲🇽Mexico City DF, Mexico
Site Reference ID/Investigator# 42108
🇲🇽Aguascalientes, Mexico
Site Reference ID/Investigator# 42107
🇲🇽Mexico City DF, Mexico
Site Reference ID/Investigator# 42109
🇲🇽Mexico City DF, Mexico
Site Reference ID/Investigator# 42114
🇲🇽Tuxtla Gutierrez, Chiapas, Mexico
Site Reference ID/Investigator# 42112
🇲🇽Tijuana, Baja California Norte, Mexico
Site Reference ID/Investigator# 42113
🇲🇽Zacatecas, Mexico
Site Reference ID/Investigator# 42115
🇲🇽Zapopan, Jalisco, Mexico
Site Reference ID/Investigator# 26350
🇻🇪Caracas, Venezuela
Site Reference ID/Investigator# 44203
🇻🇪Caracas, Venezuela
Site Reference ID/Investigator# 44204
🇻🇪Estado Carabobo, Venezuela