Trial Outcomes & Findings for Evaluation of Ubiquinol on Mitochondrial Oxidative Capacity in Statin Patients Using 31PMRS (NCT NCT01702987)

NCT ID: NCT01702987

Last Updated: 2017-04-17

Results Overview

Percentage change in phosphocreatine recovery from baseline to month as measured by 31PMRS is the primary outcome measure is a representative of mitochondrial oxidative capacity

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2017-04-17

Participant Flow

Participant milestones

Measure	Statin + Placebo 9 patients taking statin medications and placebo. placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients statin: statin was given for 1 month to 21 patients	Statin + Ubiquinol 12 patients on statins and ubiquinol ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients statin: statin was given for 1 month to 21 patients
Overall Study STARTED	10	12
Overall Study COMPLETED	9	12
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Statin + Placebo 9 patients taking statin medications and placebo. placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients statin: statin was given for 1 month to 21 patients	Statin + Ubiquinol 12 patients on statins and ubiquinol ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients statin: statin was given for 1 month to 21 patients
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Evaluation of Ubiquinol on Mitochondrial Oxidative Capacity in Statin Patients Using 31PMRS

Baseline characteristics by cohort

Measure	Statin + Placebo n=10 Participants 9 patients taking statin medications and placebo. placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients statin: statin was given for 1 month to 21 patients	Statin + Ubiquinol n=12 Participants 12 patients on statins and ubiquinol ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients statin: statin was given for 1 month to 21 patients	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 12 • n=5 Participants	53 years STANDARD_DEVIATION 7 • n=7 Participants	52 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Percentage change in phosphocreatine recovery from baseline to month as measured by 31PMRS is the primary outcome measure is a representative of mitochondrial oxidative capacity

Outcome measures

Measure	Statin + Placebo n=9 Participants 9 patients taking statin medications and placebo. placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients statin: statin was given for 1 month to 21 patients	Statin + Ubiquinol n=12 Participants 12 patients on statins and ubiquinol ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients statin: statin was given for 1 month to 21 patients
Phosphocreatine Recovery	-18.9 percentage change from baseline Standard Error 137	7.7 percentage change from baseline Standard Error 38

Adverse Events

Statin + Ubiquinol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Statin + Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jim Wu

Beth Israel Deaconess Medical Center

Phone: 617-754-2390

Email: jswu@bidmc.harvard.edu

Results disclosure agreements

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