Loading clinical trials...
Loading clinical trials...
Post-Marketing Observational Study on the Effectiveness and Safety of Niaspan® in the Treatment of Lipid Abnormalities in Latin America
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
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
Start Date
February 1, 2010
Primary Completion Date
May 1, 2012
Completion Date
May 1, 2012
Last Updated
June 6, 2014
128
ACTUAL participants
Niacin
DRUG
Lead Sponsor
Abbott
Collaborators
NCT06909773
NCT06505109
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06189313