Trial Outcomes & Findings for Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis (NCT NCT00361283)

NCT ID: NCT00361283

Last Updated: 2012-05-15

Results Overview

We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 108 participants
• Primary outcome timeframe: 16 weeks after baseline
• Results posted on: 2012-05-15

Participant Flow

University of Florida Clinical Research Center. Study started June 2004 and ended January 9, 2009.

Participant milestones

Measure	Atorvastatin 80mg of atorvastatin given once daily for 16 weeks
Overall Study STARTED	108
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	Atorvastatin 80mg of atorvastatin given once daily for 16 weeks
Overall Study Lost to Follow-up	27

Baseline Characteristics

Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

Baseline characteristics by cohort

Measure	Atorvastatin n=108 Participants 80mg of atorvastatin given once daily for 16 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	107 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	31.6 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Region of Enrollment United States	108 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks after baseline

Population: Power calculation

We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.

Outcome measures

Measure	Atorvastatin 80 MG/Day n=81 Participants Atorvastatin 80 MG/day
Mean Change in Level: Week 16-baseline in Ena-78	-111.2 pg/ml Standard Deviation 690.5

Adverse Events

Atorvastatin

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Atorvastatin n=108 participants at risk 80mg of atorvastatin given once daily for 16 weeks
Musculoskeletal and connective tissue disorders Muscle aches	13.0% 14/108 • Number of events 14 • 16 weeks
General disorders Headache	11.1% 12/108 • Number of events 12 • 16 weeks

Additional Information

Reginald F. Frye, PhD, Associate Professor

University of Florida

Phone: 3522735453

Email: fryerf@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place