CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 128 enrolled
Drug / intervention
Niacindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01200160
NCT01200160N/ACompleted

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

Abbott·observational·Posted Sep 13, 2010·Updated Jun 6, 2014

In Brief

An observational study evaluating Niacin for Cardiovascular Diseases. Completed, enrolled 128 participants across 22 sites in 3 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesColombia, Mexico, Venezuela
CollaboratorsQUASY

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2010
Enrollment StartFeb 1, 2010
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.8 years ago

Interventions

Niacindrug