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

NCT01200160 | Completed Results

• 1 other identifier: P12-055
• Study Type: observational
• Target: 128
• Locations: 3 countries
• Sites: 22

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.

Conditions

Cardiovascular Diseases

Keywords

Low-Density Lipoprotein Cholesterol; Hypertriglyceridemia; Latin America; Cardiovascular Diseases; Cholesterol; Sedentary Lifestyle; High-Density Lipoprotein Cholesterol

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Niaspan

  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.

  24 weeks regarding baseline visit (visit1)

Secondary Outcomes (3)

• Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values

  every 4 to 8 weeks for 24 weeks

• Frequency of Flushing Events

  every 4 weeks for 24 weeks

• Overall Safety and Tolerability of Niaspan

  every 4 weeks for 24 weeks

Study Arms (1)

Lipid abnormalities

Niacin

Drug: Niacin

Interventions

Niacin DRUG

Also known as: Niaspan

Lipid abnormalities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead
• QUASY: collaborator

Study Sites (22)

Site Reference ID/Investigator# 48183

Cali, 101-102, Colombia

Location

Site Reference ID/Investigator# 48182

Cali, Colombia

Location

Site Reference ID/Investigator# 42108

Aguascalientes, 20129, Mexico

Location

Site Reference ID/Investigator# 42110

Aguascalientes, 20234, Mexico

Location

Site Reference ID/Investigator# 42103

Guadalajara, Jalisco, 44657, Mexico

Location

Site Reference ID/Investigator# 42105

Metepec, Estado de Mexico, 52140, Mexico

Location

Site Reference ID/Investigator# 26348

Mexico City, C.P. 11650, Mexico

Location

Site Reference ID/Investigator# 42102

Mexico City DF, 03920, Mexico

Location

Site Reference ID/Investigator# 42107

Mexico City DF, 06359, Mexico

Location

Site Reference ID/Investigator# 42109

Mexico City DF, 11560, Mexico

Location

Site Reference ID/Investigator# 42106

Mexico City DF, 11850, Mexico

Location

Site Reference ID/Investigator# 42104

Tijuana, Baja California Norte, 11650, Mexico

Location

Site Reference ID/Investigator# 42112

Tijuana, Baja California Norte, 22420, Mexico

Location

Site Reference ID/Investigator# 42111

Tuxtla Gutierrez, Chiapas, 29000, Mexico

Location

Site Reference ID/Investigator# 42114

Tuxtla Gutierrez, Chiapas, 29030, Mexico

Location

Site Reference ID/Investigator# 42113

Zacatecas City, 98608, Mexico

Location

Site Reference ID/Investigator# 42115

Zapopan, Jalisco, 45200, Mexico

Location

Site Reference ID/Investigator# 44202

Bolívar, 8050, Venezuela

Location

Site Reference ID/Investigator# 26350

Caracas, 1010, Venezuela

Location

Site Reference ID/Investigator# 44206

Caracas, 1010, Venezuela

Location

Site Reference ID/Investigator# 44203

Caracas, 1060, Venezuela

Location

Site Reference ID/Investigator# 44204

Estado Carabobo, 2001, Venezuela

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertriglyceridemia; Sedentary Behavior

Interventions

Niacin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

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.

Results Point of Contact

• Title: Carlos A Gonzalez MD, PhD
• Organization: Abbott Laboratories de México

carlos.gonzalez@abbott.com

(5255) 5809-

Study Officials

• Enrique C Morales Villegas, MD

  Centro de Investigación Cardiometabólica

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 13, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 6, 2014
• Results First Posted: June 6, 2014

Record last verified: 2014-05

Locations

ME (15); VE (5); CO (2)