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

NCT ID: NCT01200160

Last Updated: 2014-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-05-31

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.

Conditions

Cardiovascular Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Lipid abnormalities

Niacin

Niacin

Intervention Type: DRUG

Interventions

Niacin

Intervention Type: DRUG

Other Intervention Names

Niaspan

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

QUASY

UNKNOWN

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enrique C Morales Villegas, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Investigación Cardiometabólica

Locations

Site Reference ID/Investigator# 48183

Cali, , Colombia

Site Reference ID/Investigator# 48182

Cali, , Colombia

Site Reference ID/Investigator# 42108

Aguascalientes, , Mexico

Site Reference ID/Investigator# 42110

Aguascalientes, , Mexico

Site Reference ID/Investigator# 42103

Guadalajara, Jalisco, , Mexico

Site Reference ID/Investigator# 42105

Metepec, Estado de Mexico, , Mexico

Site Reference ID/Investigator# 26348

Mexico City, , Mexico

Site Reference ID/Investigator# 42102

Mexico City DF, , Mexico

Site Reference ID/Investigator# 42107

Mexico City DF, , Mexico

Site Reference ID/Investigator# 42109

Mexico City DF, , Mexico

Site Reference ID/Investigator# 42106

Mexico City DF, , Mexico

Site Reference ID/Investigator# 42104

Tijuana, Baja California Norte, , Mexico

Site Reference ID/Investigator# 42112

Tijuana, Baja California Norte, , Mexico

Site Reference ID/Investigator# 42111

Tuxtla Gutierrez, Chiapas, , Mexico

Site Reference ID/Investigator# 42114

Tuxtla Gutierrez, Chiapas, , Mexico

Site Reference ID/Investigator# 42113

Zacatecas City, , Mexico

Site Reference ID/Investigator# 42115

Zapopan, Jalisco, , Mexico

Site Reference ID/Investigator# 44202

Bolívar, , Venezuela

Site Reference ID/Investigator# 26350

Caracas, , Venezuela

Site Reference ID/Investigator# 44206

Caracas, , Venezuela

Site Reference ID/Investigator# 44203

Caracas, , Venezuela

Site Reference ID/Investigator# 44204

Estado Carabobo, , Venezuela

Countries

Colombia; Mexico; Venezuela

Other Identifiers

P12-055

Identifier Type: -

Identifier Source: org_study_id