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Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America

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ClinicalTrials.gov Identifier: NCT01200160
Recruitment Status : Completed
First Posted : September 13, 2010
Results First Posted : June 6, 2014
Last Update Posted : June 6, 2014
Sponsor:
Collaborator:
QUASY
Information provided by (Responsible Party):
Abbott

Tracking Information
First Submitted Date September 10, 2010
First Posted Date September 13, 2010
Results First Submitted Date April 29, 2013
Results First Posted Date June 6, 2014
Last Update Posted Date June 6, 2014
Study Start Date February 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2014)
Effectiveness of Niaspan [ Time Frame: 24 weeks regarding baseline visit (visit1) ]
Increasing serum HDL-C (high-density lipoprotein - cholesterol) levels. Calculated change in different variables (Difference percent for HDL, LDL, Non-HDL and Triglycerides) was obtained using the expression: percent.change=((final.visit.variable-baseline.variable.))/(baseline.variable))*100 Then percent change is calculated at 24 weeks regarding baseline for different variables.
Original Primary Outcome Measures
 (submitted: September 10, 2010)
Effectiveness of Niaspan [ Time Frame: every 4 to 8 weeks for 24 weeks ]
Increasing serum HDL-C (high-density lipoprotein - cholesterol) levels
Change History
Current Secondary Outcome Measures
 (submitted: May 15, 2014)
  • Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values [ Time Frame: every 4 to 8 weeks for 24 weeks ]
    Evaluation of changes in non-HDL-C (non-high-density lipoproteins-cholesterol) lipids, LDL- C (low-density lipoproteins-cholesterol), total cholesterol and triglycerides (including in subjects with high triglycerides ≥ 200 mg/dL), and the impact on the Framingham score
  • Frequency of Flushing Events [ Time Frame: every 4 weeks for 24 weeks ]
    evaluate occurrence of such events over time
  • Overall Safety and Tolerability of Niaspan [ Time Frame: every 4 weeks for 24 weeks ]
    Evaluate overall safety of Niaspan through evaluation of adverse events
Original Secondary Outcome Measures
 (submitted: September 10, 2010)
  • Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values [ Time Frame: every 4 to 8 weeks for 24 weeks ]
    Evaluation of changes in non-HDL-C (non-high-density lipoproteins-cholesterol) lipids, LDL- C (low-density lipoproteins-cholesterol), total cholesterol and triglycerides (including in subjects with high triglycerides 200 mg/dL), and the impact on the Framingham score
  • Frequency of Flushing Events [ Time Frame: every 4 weeks for 24 weeks ]
    evaluate occurance of such events over time
  • Overall Safety and Tolerability of Niaspan [ Time Frame: every 4 weeks for 24 weeks ]
    Evaluate overall safety of Niaspan through evaluation of adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community sample
Condition Cardiovascular Diseases
Intervention Drug: Niacin
Other Name: Niaspan
Study Groups/Cohorts Lipid abnormalities
Niacin
Intervention: Drug: Niacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 15, 2014)
128
Original Estimated Enrollment
 (submitted: September 10, 2010)
540
Actual Study Completion Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Colombia,   Mexico,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number NCT01200160
Other Study ID Numbers P12-055
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abbott
Study Sponsor Abbott
Collaborators QUASY
Investigators
Principal Investigator: Enrique C Morales Villegas, MD Centro de Investigación Cardiometabólica
PRS Account Abbott
Verification Date May 2014