Status:
COMPLETED
Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America
Lead Sponsor:
Abbott
Collaborating Sponsors:
QUASY
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
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 obse...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01200160
Start Date
February 1 2010
End Date
May 1 2012
Last Update
June 6 2014
Active Locations (22)
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1
Site Reference ID/Investigator# 48183
Cali, Colombia, 101-102
2
Site Reference ID/Investigator# 48182
Cali, Colombia
3
Site Reference ID/Investigator# 42108
Aguascalientes, Mexico, 20129
4
Site Reference ID/Investigator# 42110
Aguascalientes, Mexico, 20234