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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Cardiovascular Diseases
Intervention Drug: Niacin
Enrollment 128
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lipid Abnormalities
Hide Arm/Group Description

No comparison groups for this observational study. Patients receive only one type of formulation, then drug exposure was the same for all patients.

This study was conducted in a prospective, single-arm, multi-center format. As this study was observational in nature, the follow-up of subject's was not prescriptive in nature and was according to the judgment of the investigator, within the period of observation set forth in the protocol.

Typically, Niaspan is titrated in the following manner: After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Ideally, Niaspan should not be increased more than 500 mg in a 4-week period and daily doses above 2000 mg are not recommended. It is expected that women may respond at lower doses than men. However, consult with the approved label for titration recommendation in the particular country.

Period Title: Overall Study
Started 128
Completed 66
Not Completed 62
Arm/Group Title Lipid Abnormalities
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 128
Hide Baseline Analysis Population Description
Intent-To-Treat (ITT) population defined as all enrolled subjects who received at least one dose of study medication
Age, Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 128 participants
<=18 years 0
Between 18 and 65 years 96
>=65 years 31
[1]
Measure Description: There were 128 recruited patients, however for one patient information about birth date is missing, then age is not possible to be calculated. Then descriptive data for "age" is for 127 patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants
55  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants
Female
53
  41.4%
Male
75
  58.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 128 participants
Mexico 53
Venezuela 60
Colombia 15
1.Primary Outcome
Title Effectiveness of Niaspan
Hide Description

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.

Time Frame 24 weeks regarding baseline visit (visit1)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HDL-Cholesterol
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[Not Specified]
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: mg/dL
41.9755  (7.56248)
2.Secondary Outcome
Title Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values
Hide Description 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
Time Frame every 4 to 8 weeks for 24 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Frequency of Flushing Events
Hide Description evaluate occurrence of such events over time
Time Frame every 4 weeks for 24 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Overall Safety and Tolerability of Niaspan
Hide Description Evaluate overall safety of Niaspan through evaluation of adverse events
Time Frame every 4 weeks for 24 weeks
Outcome Measure Data Not Reported
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lipid Abnormalities
Hide Arm/Group Description Those with the condition and exposed to the study drug
All-Cause Mortality
Lipid Abnormalities
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Lipid Abnormalities
Affected / at Risk (%) # Events
Total   0/128 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lipid Abnormalities
Affected / at Risk (%) # Events
Total   31/128 (24.22%)    
Skin and subcutaneous tissue disorders   
Flushing  31/128 (24.22%)  35
Expected sample size was not achieved due to supply issues with the new formulation in Mexico and the local decision in Colombia to cancel marketing the product in the country.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
An agreement is in place that includes a clause of keeping Abbott´s information confidential and that any publication would be performed under agreement with Abbott.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Carlos A Gonzalez MD, PhD
Organization: Abbott Laboratories de México
Phone: (5255) 5809- ext 7576
EMail: carlos.gonzalez@abbott.com
Layout table for additonal information
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01200160    
Other Study ID Numbers: P12-055
First Submitted: September 10, 2010
First Posted: September 13, 2010
Results First Submitted: April 29, 2013
Results First Posted: June 6, 2014
Last Update Posted: June 6, 2014