Cardiovascular DiseasesNCT01200160
Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America
An observational study of Cardiovascular Diseases, run by Abbott at 22 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Niacin
- How many people
- 128 participants
- Where
- 22 sitesin 3 countries
- Study dates
- Feb 2010to May 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
Mexico15 sites
Site Reference ID/Investigator# 42108
Aguascalientes, 20129
Site Reference ID/Investigator# 42110
Aguascalientes, 20234
Site Reference ID/Investigator# 42103
Guadalajara, Jalisco, 44657
Site Reference ID/Investigator# 42105
Metepec, Estado de Mexico, 52140
Site Reference ID/Investigator# 26348
Mexico City, C.P. 11650
Site Reference ID/Investigator# 42102
Mexico City DF, 03920
Site Reference ID/Investigator# 42107
Mexico City DF, 06359
Site Reference ID/Investigator# 42109
Mexico City DF, 11560
Site Reference ID/Investigator# 42106
Mexico City DF, 11850
Site Reference ID/Investigator# 42104
Tijuana, Baja California Norte, 11650
Site Reference ID/Investigator# 42112
Tijuana, Baja California Norte, 22420
Site Reference ID/Investigator# 42111
Tuxtla Gutierrez, Chiapas, 29000
Site Reference ID/Investigator# 42114
Tuxtla Gutierrez, Chiapas, 29030
Site Reference ID/Investigator# 42113
Zacatecas City, 98608
Site Reference ID/Investigator# 42115
Zapopan, Jalisco, 45200
Venezuela5 sites
Site Reference ID/Investigator# 44202
Bolívar, 8050
Site Reference ID/Investigator# 26350
Caracas, 1010
Site Reference ID/Investigator# 44206
Caracas, 1010
Site Reference ID/Investigator# 44203
Caracas, 1060
Site Reference ID/Investigator# 44204
Estado Carabobo, 2001
Colombia2 sites
Site Reference ID/Investigator# 48183
Cali, 101-102
Site Reference ID/Investigator# 48182
Cali
About this study
Official title: Post-Marketing Observational Study on the Effectiveness and Safety of Niaspan® in the Treatment of Lipid Abnormalities in Latin America
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Niacin
- Keywords
- Low-Density Lipoprotein Cholesterol, Hypertriglyceridemia, Latin America, Cardiovascular Diseases, Cholesterol, Sedentary Lifestyle, High-Density Lipoprotein Cholesterol
- Medical subject headings
- Cardiovascular Diseases, Hypertriglyceridemia, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiacinDrug
Also called Niaspan
| Study group | Role | What they receive |
|---|---|---|
| Lipid abnormalities | Niacin Receives: Drug: Niacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks regarding baseline visit (visit1)
Secondary outcomes (3)
Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values
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
Measured: every 4 to 8 weeks for 24 weeks
Frequency of Flushing Events
evaluate occurrence of such events over time
Measured: every 4 weeks for 24 weeks
Overall Safety and Tolerability of Niaspan
Evaluate overall safety of Niaspan through evaluation of adverse events
Measured: every 4 weeks for 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QUASY
- Responsible party
- Sponsor
- Investigators
- Enrique C Morales Villegas, MD, Principal investigator, Centro de Investigación Cardiometabólica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200160
- Sponsor's protocol ID
- P12-055
- Status last verified
- May 2014
- First submitted
- 10 Sep 2010
- Last updated
- 6 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Observational Study on the Effectiveness and Safety of Niaspan® in the Treatment of Lipid Abnormalities in Latin America
- ClinicalTrials.gov ID
- NCT01200160
- Acronym / sponsor ID
- P12-055
- Conditions
- Cardiovascular Diseases
- Keywords
- Low-Density Lipoprotein Cholesterol, Hypertriglyceridemia, Latin America, Cardiovascular Diseases, Cholesterol, Sedentary Lifestyle, High-Density Lipoprotein Cholesterol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- QUASY
- Study start
- Feb 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Posted 6 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipid abnormalities | – | Drug: NiacinNiacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiacinAlso: Niaspan | Drug | Lipid abnormalities |
Primary outcome
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.
3 secondary outcomes
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
Frequency of Flushing Events
Time frame: every 4 weeks for 24 weeks
Overall Safety and Tolerability of Niaspan
Time frame: every 4 weeks for 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique C Morales Villegas, MD principal investigator
Centro de Investigación Cardiometabólica
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Abbott at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Mexico, Venezuela, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Niaspan (time frame: 24 weeks regarding baseline visit (visit1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014.