Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America

Condition(s) targeted: Cardiovascular Diseases

Intervention: Niacin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Enrique C Morales Villegas, MD, Principal Investigator, Affiliation: Centro de Investigación Cardiometabólica

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.

Official title: Post-Marketing Observational Study on the Effectiveness and Safety of Niaspan® in the Treatment of Lipid Abnormalities in Latin America

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Effectiveness of Niaspan

Secondary outcome:

Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values

Frequency of Flushing Events

Overall Safety and Tolerability of Niaspan

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria

- Male and female subject >18 years-old

- Subjects with primary hyperlipidemia or mixed dyslipidemia with elevated levels of

total cholesterol,, LDL-C (low-density lipoprotein-cholesterol), triglycerides and/or decreased levels of HDL-C (high-density lipoprotein-cholesterol) (< 40 mg/dL) and has demonstrated an inadequate response to a lipid-restricted diet and other non-pharmacologic measures alone such as exercise

- Subject has demonstrated persistent dyslipidemic values and/or inadequate response or

intolerance to other pharmacologic therapies such as statins, fibrates, resins, etc.

- Female subjects with reproductive potential must use an approved contraceptive method

(intrauterine device (IUD), birth control pills or barrier device) during and for 3 months after discontinuation of study treatment. Exclusion Criteria

- Subject has been treated with any other investigational product in the last 30 days

before the day of the screening visit

- Subject exhibits signs of acute illness with clinically relevant findings in the

pre-study examination

- Subject has known hypersensitivity to niacin or any component of Niaspan®

- Subject has significant or unexplained hepatic and/or renal dysfunction

- Subject has active peptic ulcer disease

- Subject exhibits active arterial bleeding

- Subject is pregnant or lactating

- The mental condition of the subject renders him/her unable to understand the nature,

scope, and possible consequences of the study

- Subject is unlikely to comply with the protocol, e. g., uncooperative attitude,

inability to return for follow-up visits, and unlikelihood of completing the study

Site Reference ID/Investigator# 48182, Cali, Colombia

Site Reference ID/Investigator# 48183, Cali 101-102, Colombia

Site Reference ID/Investigator# 42108, Aguascalientes 20129, Mexico

Site Reference ID/Investigator# 42110, Aguascalientes 20234, Mexico

Site Reference ID/Investigator# 42103, Guadalajara, Jalisco 44657, Mexico

Site Reference ID/Investigator# 42105, Metepec, Estado de Mexico 52140, Mexico

Site Reference ID/Investigator# 42102, Mexico City DF 03920, Mexico

Site Reference ID/Investigator# 42106, Mexico City DF 11850, Mexico

Site Reference ID/Investigator# 42107, Mexico City DF 06359, Mexico

Site Reference ID/Investigator# 42109, Mexico City DF 11560, Mexico

Site Reference ID/Investigator# 26348, Mexico D.F. C.P. 11650, Mexico

Site Reference ID/Investigator# 42104, Tijuana, Baja California Norte 11650, Mexico

Site Reference ID/Investigator# 42112, Tijuana, Baja California Norte 22420, Mexico

Site Reference ID/Investigator# 42111, Tuxtla Gutierrez, Chiapas 29000, Mexico

Site Reference ID/Investigator# 42114, Tuxtla Gutierrez, Chiapas 29030, Mexico

Site Reference ID/Investigator# 42113, Zacatecas 98608, Mexico

Site Reference ID/Investigator# 42115, Zapopan, Jalisco 45200, Mexico

Site Reference ID/Investigator# 44202, Bolivar 8050, Venezuela

Site Reference ID/Investigator# 26350, Caracas 1010, Venezuela

Site Reference ID/Investigator# 44203, Caracas 1060, Venezuela

Site Reference ID/Investigator# 44206, Caracas 1010, Venezuela

Site Reference ID/Investigator# 44204, Estado Carabobo 2001, Venezuela

Starting date: February 2010
Last updated: May 15, 2014