Clinical trial NCT01200160: Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America
Official title: Post-Marketing Observational Study on the Effectiveness and Safety of Niaspan® in the Treatment of Lipid Abnormalities in Latin America
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Low-Density Lipoprotein Cholesterol
Hypertriglyceridemia
Latin America
Cardiovascular Diseases
Cholesterol
Sedentary Lifestyle
High-Density Lipoprotein Cholesterol
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: QUASY
First posted: 2010-09-13
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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.

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

Primary outcomes:
measure: Effectiveness of Niaspan
timeFrame: 24 weeks regarding baseline visit (visit1)
Secondary outcomes:
measure: Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values
timeFrame: every 4 to 8 weeks for 24 weeks
measure: Frequency of Flushing Events
timeFrame: every 4 weeks for 24 weeks
measure: Overall Safety and Tolerability of Niaspan
timeFrame: every 4 weeks for 24 weeks
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Site Reference ID/Investigator# 48183
city: Cali
country: Colombia
facility: Site Reference ID/Investigator# 48182
city: Aguascalientes
country: Mexico
facility: Site Reference ID/Investigator# 42108
city: Aguascalientes
country: Mexico
facility: Site Reference ID/Investigator# 42110
city: Guadalajara, Jalisco
country: Mexico
facility: Site Reference ID/Investigator# 42103
city: Metepec, Estado de Mexico
country: Mexico
facility: Site Reference ID/Investigator# 42105
city: Mexico City DF
country: Mexico
facility: Site Reference ID/Investigator# 42102
city: Mexico City DF
country: Mexico
facility: Site Reference ID/Investigator# 42107
city: Mexico City DF
country: Mexico
facility: Site Reference ID/Investigator# 42109
city: Mexico City DF
country: Mexico
facility: Site Reference ID/Investigator# 42106
city: Mexico D.F.
country: Mexico
facility: Site Reference ID/Investigator# 26348
city: Tijuana, Baja California Norte
country: Mexico
facility: Site Reference ID/Investigator# 42104
city: Tijuana, Baja California Norte
country: Mexico
facility: Site Reference ID/Investigator# 42112
city: Tuxtla Gutierrez, Chiapas
country: Mexico
facility: Site Reference ID/Investigator# 42111
city: Tuxtla Gutierrez, Chiapas
country: Mexico
facility: Site Reference ID/Investigator# 42114
city: Zacatecas
country: Mexico
facility: Site Reference ID/Investigator# 42113
city: Zapopan, Jalisco
country: Mexico
facility: Site Reference ID/Investigator# 42115
city: Bolivar
country: Venezuela
facility: Site Reference ID/Investigator# 44202
city: Caracas
country: Venezuela
facility: Site Reference ID/Investigator# 26350
city: Caracas
country: Venezuela
facility: Site Reference ID/Investigator# 44206
city: Caracas
country: Venezuela
facility: Site Reference ID/Investigator# 44203
city: Estado Carabobo
country: Venezuela
facility: Site Reference ID/Investigator# 44204
Study officials:
affiliation: Centro de Investigación Cardiometabólica
name: Enrique C Morales Villegas, MD
role: PRINCIPAL_INVESTIGATOR
References: