DyslipidemiaPhase 3ASA EFFECTSNCT00626392

Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia

A Phase 3 study testing niacin extended-release (NER) and aspirin (ASA) in people with Dyslipidemia, run by Abbott at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study was to assess the effect of aspirin (ASA) on niacin extended-release (NER)-induced flushing in subjects with dyslipidemia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dyslipidemia
What is being tested?: niacin extended-release (NER) and aspirin (ASA)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 277 participants
Where: 26 sitesUnited States
Study dates: Feb 2008to Apr 2008
Phase: Phase 3
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject must be 18 years of age or older.
If female, subject is either not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile, or is of childbearing potential and must agree to practice birth control for the duration of the study.
Have dyslipidemia as demonstrated by laboratory results.

Who cannot join

Have glycosylated hemoglobin (HbA1c) >/= 9.0%.
Have nephrotic syndrome, dysproteinemias, or severe renal failure (glomerular filtration rate [GFR] < 30 mL/minute, as calculated from creatinine clearance).
Have had unstable angina or an acute myocardial infarction (MI) within three months of the Screening Visit.
Have had severe peripheral artery disease as evidenced by intermittent claudication within three months of the Screening Visit.
Have had uncontrolled cardiac arrhythmias within three months of the Screening Visit.
Have symptomatic heart failure defined as dyspnea at rest or with exertion (mild peripheral edema is not exclusionary).

Show all 12Show fewer

Have a systolic blood pressure measurement of > 180 mmHg or a diastolic blood pressure measurement of > 110 mmHg at the Screening or Baseline Visit.
Have active gout or uric acid >/= 11 mg/dL.
Have a history of hepatitis (acute or chronic), obstructive liver disease, or alanine aminotransferase (ALT; serum glutamic pyruvic transaminase [SGPT]) or aspartate aminotransferase (AST; serum glutamic oxaloacetic transaminase [SGOT]) values >/= 1.3 times the upper limit of normal (ULN) at the Screening Visit.
Have creatine phosphokinase (CPK) >/= 3 x ULN at the Screening Visit.
Have used an investigational study drug or participated in an investigational study within 30 days of the Screening Visit.
Have a health condition or laboratory abnormality (inclusive of clinically significant laboratory results at Screening Visit), which, in the opinion of the Investigator, may be adversely affected by the procedures or study medications in this study.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Study site
Anaheim, California, 92801
Study site
Charlotte, North Carolina, 28262
Study site
Colleyville, Texas, 76034
Study site
Coral Gables, Florida, 33134
Study site
Houston, Texas, 77074
Study site
Huntsville, Alabama, 35801
Study site
Jacksonville, Florida, 32259
Study site
Johnston, Rhode Island, 02919
Study site
Los Angeles, California, 90057
Study site
Miami, Florida, 33186
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Newport Beach, California, 92660
Study site
North Dartmouth, Massachusetts, 02747
Study site
Pembroke Pines, Florida, 33027
Study site
Penndel, Pennsylvania, 19047
Study site
Rochester, New York, 14609
Study site
San Antonio, Texas, 78229
Study site
Scottsdale, Arizona, 85251
Study site
Simpsonville, South Carolina, 29681
Study site
Stockton, California, 95204
Study site
Tucson, Arizona, 85710
Study site
Tucson, Arizona, 85712
Study site
Vista, California, 90057
Study site
West Palm Beach, Florida, 33407
Study site
Westlake Village, California, 91361
Study site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Multicenter, Randomized, Double-Blind, Parallel, Acetylsalicylic Acid (ASA) Run-In Study to Evaluate the EFFECTS of Acetylsalicylic Acid on Niaspan®-Induced Flushing in Subjects With Dyslipidemia

The primary purpose of this study was to assess the effect of aspirin (ASA) on niacin extended-release (NER)-induced flushing in subjects with dyslipidemia.

Conditions: Dyslipidemia
Being tested: niacin extended-release (NER), aspirin (ASA), aspirin placebo (ASA Pbo)
Medical subject headings: Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

niacin extended-release (NER)Drug
Also called Niaspan
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
aspirin (ASA)Drug
Also called acetylsalicylic acid
325 mg tablets administered once daily
aspirin placebo (ASA Pbo)Drug
Also called placebo
Tablets administered once daily

Study groups in NCT00626392
Study group	Role	What they receive
NER 500; ASA run-in, ASA coadmin	Experimental	Aspirin (ASA) daily during run-in (1 week); ASA 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration period (4 weeks) Receives: Drug: niacin extended-release (NER); Drug: aspirin (ASA)
NER 500; ASA Pbo run-in, ASA coadmin	Experimental	Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration period (4 weeks) Receives: Drug: niacin extended-release (NER); Drug: aspirin (ASA); Drug: aspirin placebo (ASA Pbo)
NER 500; ASA Pbo run-in, ASA Pbo coadmin	Experimental	Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration period (4 weeks) Receives: Drug: niacin extended-release (NER); Drug: aspirin placebo (ASA Pbo)
NER 1000; ASA run-in, ASA coadmin	Experimental	Aspirin (ASA) daily during run-in (1 week); ASA 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration period (4 weeks) Receives: Drug: niacin extended-release (NER); Drug: aspirin (ASA)
NER 1000; ASA Pbo run-in, ASA coadmin	Experimental	Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration period (4 weeks) Receives: Drug: niacin extended-release (NER); Drug: aspirin (ASA); Drug: aspirin placebo (ASA Pbo)
NER 1000; ASA Pbo run-in, ASA Pbo coadmin	Experimental	Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration period (4 weeks) Receives: Drug: niacin extended-release (NER); Drug: aspirin placebo (ASA Pbo)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.
Measured: From Baseline to end of Week 1

Secondary outcomes (3)

Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
The maximum severity of flushing events subjects experienced during 4 weeks of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.
Measured: 4 weeks
Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
Subjects assessed the severity of flushing events on a 10-point numeric rating scale of 1-3 (mild), 4-6 (moderate), 7-9 (severe), and 10 (very severe) using the Flushing Assessment Tool via an e-diary. For subjects who did not experience flushing, a score of 0 was assigned. Flushing was assessed daily.
Measured: 4 weeks
Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
Flushing was assessed daily using the Flushing Assessment Tool via an e-diary and the mean number of flushing events per subject per week considered moderate or greater in severity was calculated. Flushing events were rated by the subject using a categorical scale of mild, moderate, severe, or very severe.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Apr 2008

First posted29 Feb 2008 (estimated)
Study startFeb 2008
Primary completionApr 2008
Study completionApr 2008

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DyslipidemiaStudies 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 277 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00626392
Sponsor's protocol ID: M10-241
Acronym: ASA EFFECTS
Status last verified: Aug 2009
First submitted: 21 Feb 2008
Last updated: 2 Sep 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Thakkar RB, Kashyap ML, Lewin AJ, Krause SL, Jiang P, Padley RJ. Acetylsalicylic acid reduces niacin extended-release-induced flushing in patients with dyslipidemia. Am J Cardiovasc Drugs. 2009;9(2):69-79. doi: 10.1007/BF03256578.
PubMed 19331435

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Randomized, Double-Blind, Parallel, Acetylsalicylic Acid (ASA) Run-In Study to Evaluate the EFFECTS of Acetylsalicylic Acid on Niaspan®-Induced Flushing in Subjects With Dyslipidemia
ClinicalTrials.gov ID: NCT00626392
Acronym / sponsor ID: ASA EFFECTS / M10-241
Conditions: Dyslipidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 277 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 29 Feb 2008 (estimated)
Results: Posted 25 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of this study was to assess the effect of aspirin (ASA) on niacin extended-release (NER)-induced flushing in subjects with dyslipidemia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
NER 500; ASA run-in, ASA coadmin	Experimental	Drug: niacin extended-release (NER), Drug: aspirin (ASA)Aspirin (ASA) daily during run-in (1 week); ASA 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration period (4 weeks)
NER 500; ASA Pbo run-in, ASA coadmin	Experimental	Drug: niacin extended-release (NER), Drug: aspirin (ASA), Drug: aspirin placebo (ASA Pbo)Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration period (4 weeks)
NER 500; ASA Pbo run-in, ASA Pbo coadmin	Experimental	Drug: niacin extended-release (NER), Drug: aspirin placebo (ASA Pbo)Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration period (4 weeks)
NER 1000; ASA run-in, ASA coadmin	Experimental	Drug: niacin extended-release (NER), Drug: aspirin (ASA)Aspirin (ASA) daily during run-in (1 week); ASA 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration period (4 weeks)
NER 1000; ASA Pbo run-in, ASA coadmin	Experimental	Drug: niacin extended-release (NER), Drug: aspirin (ASA), Drug: aspirin placebo (ASA Pbo)Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration period (4 weeks)
NER 1000; ASA Pbo run-in, ASA Pbo coadmin	Experimental	Drug: niacin extended-release (NER), Drug: aspirin placebo (ASA Pbo)Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration period (4 weeks)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subject must be 18 years of age or older.
If female, subject is either not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile, or is of childbearing potential and must agree to practice birth control for the duration of the study.
Have dyslipidemia as demonstrated by laboratory results.

Key exclusion criteria (12 listed)

Have glycosylated hemoglobin (HbA1c) >/= 9.0%.
Have nephrotic syndrome, dysproteinemias, or severe renal failure (glomerular filtration rate [GFR] < 30 mL/minute, as calculated from creatinine clearance).
Have had unstable angina or an acute myocardial infarction (MI) within three months of the Screening Visit.
Have had severe peripheral artery disease as evidenced by intermittent claudication within three months of the Screening Visit.
Have had uncontrolled cardiac arrhythmias within three months of the Screening Visit.

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
niacin extended-release (NER)Also: NiaspanTablets administered once daily; titrated to 2000 mg maximum dose during coadministration period	Drug	NER 1000; ASA Pbo run-in, ASA Pbo coadmin, NER 1000; ASA Pbo run-in, ASA coadmin, NER 1000; ASA run-in, ASA coadmin, NER 500; ASA Pbo run-in, ASA Pbo coadmin, NER 500; ASA Pbo run-in, ASA coadmin, NER 500; ASA run-in, ASA coadmin
aspirin (ASA)Also: acetylsalicylic acid325 mg tablets administered once daily	Drug	NER 1000; ASA Pbo run-in, ASA coadmin, NER 1000; ASA run-in, ASA coadmin, NER 500; ASA Pbo run-in, ASA coadmin, NER 500; ASA run-in, ASA coadmin
aspirin placebo (ASA Pbo)Also: placeboTablets administered once daily	Drug	NER 1000; ASA Pbo run-in, ASA Pbo coadmin, NER 1000; ASA Pbo run-in, ASA coadmin, NER 500; ASA Pbo run-in, ASA Pbo coadmin, NER 500; ASA Pbo run-in, ASA coadmin

Primary outcome

Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
Time frame: From Baseline to end of Week 1
The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.

3 secondary outcomes

Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
Time frame: 4 weeks
Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
Time frame: 4 weeks
Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
Time frame: 4 weeks

Results and safety

Results posted to the registry on 25 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NER 500; ASA run-in, ASA Coadmin	45	44
NER 500; ASA Pbo run-in, ASA Coadmin	44	43
NER 500; ASA Pbo run-in, ASA Pbo Coadmin	44	41
NER 1000; ASA run-in; ASA Coadmin	44	43
NER 1000; ASA Pbo run-in, ASA Coadmin	45	41
NER 1000; ASA Pbo run-in, ASA Pbo Coadmin	45	44

Primary outcome: Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment

Time frame: From Baseline to end of Week 1. Number. Unit: Percentage of Subjects

Measure	Any Acetylsalicylic Acid n = 167	No Acetylsalicylic Acid n = 84
None	57	48
Mild	28	24
None/mild	85	71
Moderate	11	17
Severe	4	8
Very severe	1	4

Any Acetylsalicylic Acid vs No Acetylsalicylic Acid: p = 0.010, Cochran-Mantel-Haenszel

Population analysed: All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Any Acetylsalicylic Acid	1 of ?	119 of ?	Not reported
No Acetylsalicylic Acid	1 of ?	72 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19331435Thakkar RB, Kashyap ML, Lewin AJ, Krause SL, Jiang P, Padley RJ. Acetylsalicylic acid reduces niacin extended-release-induced flushing in patients with dyslipidemia. Am J Cardiovasc Drugs. 2009;9(2):69-79. doi: 10.1007/BF03256578.

Related trials for Dyslipidemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
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Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
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A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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.

Roopal Thakkar, MD study director

Abbott

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing niacin extended-release (NER) and aspirin (ASA) in people with Dyslipidemia, run by Abbott at 26 sites in United States.

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 3 inclusion and 12 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 2 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2009). 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?

Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment (time frame: From Baseline to end of Week 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00626392, which also lists 1 linked publication.

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 2 Sep 2009.