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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200160
• Other study ID #: P12-055
• Status: Completed
• Phase: N/A
• First received: September 10, 2010
• Last updated: May 15, 2014
• Start date: February 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2014
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Ministry of Health and Social DevelopmentMexico: Federal Commission for Protection Against Health RisksColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Niacin

Locations

Country	Name	City	State
Colombia	Site Reference ID/Investigator# 48182	Cali
Colombia	Site Reference ID/Investigator# 48183	Cali
Mexico	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# 42102	Mexico City DF
Mexico	Site Reference ID/Investigator# 42106	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# 26348	Mexico D.F.
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
Mexico	Site Reference ID/Investigator# 42115	Zapopan, Jalisco
Venezuela	Site Reference ID/Investigator# 44202	Bolivar
Venezuela	Site Reference ID/Investigator# 26350	Caracas
Venezuela	Site Reference ID/Investigator# 44203	Caracas
Venezuela	Site Reference ID/Investigator# 44206	Caracas
Venezuela	Site Reference ID/Investigator# 44204	Estado Carabobo

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	QUASY

Countries where clinical trial is conducted

Colombia,  Mexico,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Niaspan	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.	24 weeks regarding baseline visit (visit1)	No
Secondary	Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values	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	every 4 to 8 weeks for 24 weeks	No
Secondary	Frequency of Flushing Events	evaluate occurrence of such events over time	every 4 weeks for 24 weeks	Yes
Secondary	Overall Safety and Tolerability of Niaspan	Evaluate overall safety of Niaspan through evaluation of adverse events	every 4 weeks for 24 weeks	Yes