Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America
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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 |
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Recruitment Status :
Completed
First Posted : September 13, 2010
Results First Posted : June 6, 2014
Last Update Posted : June 6, 2014
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| Condition or disease | Intervention/treatment |
|---|---|
| Cardiovascular Diseases | Drug: Niacin |
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 |
| Actual Enrollment : | 128 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Post-Marketing Observational Study on the Effectiveness and Safety of Niaspan® in the Treatment of Lipid Abnormalities in Latin America |
| Study Start Date : | February 2010 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | May 2012 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Lipid abnormalities
Niacin
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Drug: Niacin
Other Name: Niaspan |
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200160
Show 22 study locations
| Principal Investigator: | Enrique C Morales Villegas, MD | Centro de Investigación Cardiometabólica |
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT01200160 |
| Other Study ID Numbers: |
P12-055 |
| First Posted: | September 13, 2010 Key Record Dates |
| Results First Posted: | June 6, 2014 |
| Last Update Posted: | June 6, 2014 |
| Last Verified: | May 2014 |
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Low-Density Lipoprotein Cholesterol Hypertriglyceridemia Latin America Cardiovascular Diseases |
Cholesterol Sedentary Lifestyle High-Density Lipoprotein Cholesterol |
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Cardiovascular Diseases Niacin Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents |
Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |