Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
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.
Clinical Details
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 ValuesFrequency 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.
Eligibility
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
Locations and Contacts
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
Additional Information
Starting date: February 2010
Last updated: May 15, 2014
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