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Niacin

Phase 3

Dyslipidemia | Small molecule | Metabolic |Abbott Laboratories|Last Updated: Oct 9, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment553
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00626392Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With DyslipidemiaPHASE3 COMPLETED 277Feb 1, 2008Apr 1, 2008Sep 2, 200926 United States
NCT00630877Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus AspirinPHASE3 COMPLETED 276Feb 1, 2008Jun 1, 2008Oct 9, 200940 United States
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Study Endpoints
Primary Endpoints
Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
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.

Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score
Week 1 to Week 2

Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.

FAST Test-retest Reliability--maximum Flushing Severity Score
Week 1 to Week 2

Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.

FAST Cross-sectional Construct Validity--mean Flushing Severity Score
Week 1

The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.

FAST Cross-sectional Construct Validity--maximum Flushing Severity Score
Week 1

The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.

FAST Longitudinal Construct Validity--mean Flushing Severity Score
Week 1 to Week 2

The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).

FAST Longitudinal Construct Validity--maximum Flushing Severity Score
Week 1 to Week 2

The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).

FAST Responsiveness--mean Flushing Severity Score
Study start to Day 43

The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.

FAST Responsiveness--maximum Flushing Severity Score
Study start to Day 43

The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.

Secondary Endpoints
Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
4 weeks
Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
4 weeks
Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment
4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NER 500; ASA run-in, ASA coadminEXPERIMENTALAspirin (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 coadminEXPERIMENTALAspirin 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 coadminEXPERIMENTALAspirin 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 coadminEXPERIMENTALAspirin (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 coadminEXPERIMENTALAspirin 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 coadminEXPERIMENTALAspirin 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)
NER/ASAEXPERIMENTAL -
NER/ASA PlaceboEXPERIMENTAL -
NER Placebo/ASA PlaceboEXPERIMENTAL -
Interventions
NameTypeDescription
niacin extended-release (NER)DRUGTablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
aspirin (ASA)DRUG325 mg tablets administered once daily
aspirin placebo (ASA Pbo)DRUGTablets administered once daily
Niacin extended-release (NER) placeboDRUGTablets administered once daily for 6 weeks
Aspirin (ASA) placeboDRUGTablets administered once daily for 6 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * 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...

Countries:United States
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