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

This study has been completed.
Sponsor:
Collaborator:
QUASY
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01200160
First received: September 10, 2010
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Drug: Niacin

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Effectiveness of Niaspan [ Time Frame: 24 weeks regarding baseline visit (visit1) ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    evaluate occurrence of such events over time

  • Overall Safety and Tolerability of Niaspan [ Time Frame: every 4 weeks for 24 weeks ] [ Designated as safety issue: Yes ]
    Evaluate overall safety of Niaspan through evaluation of adverse events


Enrollment: 128
Study Start Date: February 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lipid abnormalities
Niacin
Drug: Niacin
Other Name: Niaspan

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200160

Locations
Colombia
Site Reference ID/Investigator# 48182
Cali, Colombia
Site Reference ID/Investigator# 48183
Cali, Colombia, 101-102
Mexico
Site Reference ID/Investigator# 42108
Aguascalientes, Mexico, 20129
Site Reference ID/Investigator# 42110
Aguascalientes, Mexico, 20234
Site Reference ID/Investigator# 42103
Guadalajara, Jalisco, Mexico, 44657
Site Reference ID/Investigator# 42105
Metepec, Estado de Mexico, Mexico, 52140
Site Reference ID/Investigator# 42102
Mexico City DF, Mexico, 03920
Site Reference ID/Investigator# 42106
Mexico City DF, Mexico, 11850
Site Reference ID/Investigator# 42107
Mexico City DF, Mexico, 06359
Site Reference ID/Investigator# 42109
Mexico City DF, Mexico, 11560
Site Reference ID/Investigator# 26348
Mexico D.F., Mexico, C.P. 11650
Site Reference ID/Investigator# 42104
Tijuana, Baja California Norte, Mexico, 11650
Site Reference ID/Investigator# 42112
Tijuana, Baja California Norte, Mexico, 22420
Site Reference ID/Investigator# 42111
Tuxtla Gutierrez, Chiapas, Mexico, 29000
Site Reference ID/Investigator# 42114
Tuxtla Gutierrez, Chiapas, Mexico, 29030
Site Reference ID/Investigator# 42113
Zacatecas, Mexico, 98608
Site Reference ID/Investigator# 42115
Zapopan, Jalisco, Mexico, 45200
Venezuela
Site Reference ID/Investigator# 44202
Bolivar, Venezuela, 8050
Site Reference ID/Investigator# 26350
Caracas, Venezuela, 1010
Site Reference ID/Investigator# 44203
Caracas, Venezuela, 1060
Site Reference ID/Investigator# 44206
Caracas, Venezuela, 1010
Site Reference ID/Investigator# 44204
Estado Carabobo, Venezuela, 2001
Sponsors and Collaborators
Abbott
QUASY
Investigators
Principal Investigator: Enrique C Morales Villegas, MD Centro de Investigación Cardiometabólica
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01200160     History of Changes
Other Study ID Numbers: P12-055
Study First Received: September 10, 2010
Results First Received: April 29, 2013
Last Updated: May 15, 2014
Health Authority: Venezuela: Ministry of Health and Social Development
Mexico: Federal Commission for Protection Against Health Risks
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Abbott:
Low-Density Lipoprotein Cholesterol
Hypertriglyceridemia
Latin America
Cardiovascular Diseases
Cholesterol
Sedentary Lifestyle
High-Density Lipoprotein Cholesterol

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014