Trial Outcomes & Findings for 7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events (NCT NCT04507373)

Results Overview

Study participants being treated with Simvastatin 40mg daily, or placebo for 10 weeks. Investigators will isolate mitochondrial from muscle biopsy sample and compare mitochondrial oxygen consumption rates, ultrastructural changes, and gene expression

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

10 weeks

Results posted on

2023-02-14

Participant Flow

The 3 participants who were consented/ enrolled were not assigned/ randomized to the interventions because no grant was obtained for the study to continue further and the study was terminated.

Participant milestones

Participant milestones
Measure	Placebo Following the baseline period, subject will be randomized to receive either simvastatin or an identical placebo at a dose of 40 mg/day for a period of 10 weeks. Simvastatin 40mg: 40mg oral daily for 10 weeks	Simvastatin 40mg Following the baseline period, subject will be randomized to receive either simvastatin or an identical placebo at a dose of 40 mg/day for a period of 10 weeks. Simvastatin 40mg: 40mg oral daily for 10 weeks
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 10 weeks

Population: The participants who were consented/ enrolled were not assigned/ randomized to the interventions because no grant was obtained for the study to continue further and the study was terminated.

Study participants being treated with Simvastatin 40mg daily, or placebo for 10 weeks. Investigators will isolate mitochondrial from muscle biopsy sample and compare mitochondrial oxygen consumption rates, ultrastructural changes, and gene expression

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Simvastatin 40mg

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

Dr. Zahid Ahmad

UT Southwestern Medical Center

Phone: 214/648-2377

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place