A Phase 4 interventional study of Statins and Placebo in Statin Adverse Reaction, sponsored by Rockefeller University. Terminated at 1 site in United States. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-11-06.
Sponsored by Rockefeller University · Phase 4 and Interventional
The proposed study will focus on possible effects of statins on muscle strength and why they become tired more easily, quality of life, and measurements to understand why muscles are not able to fully utilize fats. The investigators are specifically interested in statin users and the impact of muscle symptoms on daily activities and quality of life.
This study hypothesize that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show:
The proposed study will focus on possible effects of statins on muscle strength and quality of life, and measurements to understand why muscles of statin users are not able to fully utilize fats. The investigators are specifically interested in statin users and the impact of muscle symptoms on daily activities and quality of life.
This study hypothesizes that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show:
Rockefeller University is the lead sponsor of 120 studies on the registry; 3 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusions for the metabolic study:
Lactose placebo pill
Drug: Placebo
Statin medications
Drug: Statins
Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth.
Also known as: atorvastatin, simvastatin, pravastatin, rosuvastatin
Placebo pills will consist of lactose and will be given one capsule once daily
Also known as: lactose pills
Individualized Neuromuscular Quality of Life (INQoL) Mean Scores From Week 0 to Week 8
Scores from the self-administered INQoL questionnaire will be compared at the start of the study (Week 0) and at the end (Week 8) between the statin-treated group and the placebo group. Scores range from 0-100, with 100 being a better outcome. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of the results (3 per group).
Time frame: Week 0 to Week 8
Individualized Short Form-36 (SF-36) Mean Scores (Physical Component) From Week 0 to Week 8
Scores from the self-administered SF-36 (Physical component) questionnaire were measured at the start (Week 0) of the study and at the end (Week 8) among patients in the placebo- and statin-treated group. Mean scores range from 0 (minimum) - 100 (maximum) with higher mean scores reflecting better outcomes. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of scores.
Time frame: Week 0 to Week 8
Advertisements were placed (internet, radio, print) and a screening phone questionnaire was administered by study staff to determine potential inclusion. A collaboration with the Metropolitan Hospital (NY) was also established for potential referrals.
| Milestone | Placebo | Statins |
|---|---|---|
| Started | 7 | 7 |
| Started - week 0 | 7 | 7 |
| Completion - week 8 | 3 | 3 |
| Completed | 3 | 3 |
| Not completed | 4 | 4 |
| Withdrew: Lost to follow-up | 4 | 4 |
Scores from the self-administered INQoL questionnaire will be compared at the start of the study (Week 0) and at the end (Week 8) between the statin-treated group and the placebo group. Scores range from 0-100, with 100 being a better outcome. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of the results (3 per group).
| units on a scale | Placebo | Statins |
|---|---|---|
| Week 0 Mean Score | 65 (43.9 to 95) | 76 (67.2 to 81.7) |
| Week 8 Mean Score | 67 (53.3 to 88.3) | 50 (43.9 to 60.6) |
Scores from the self-administered SF-36 (Physical component) questionnaire were measured at the start (Week 0) of the study and at the end (Week 8) among patients in the placebo- and statin-treated group. Mean scores range from 0 (minimum) - 100 (maximum) with higher mean scores reflecting better outcomes. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of scores.
| units on a scale | Placebo | Statins |
|---|---|---|
| Week 0 Mean Score | 50 (45.7 to 58) | 53 (49.7 to 54.4) |
| Week 8 Mean Score | 56 (53.8 to 58.6) | 48 (47.3 to 48.2) |
Collected over Adverse event data were collected from the time the subjects were enrolled in the study until study termination (eight weeks). The study ran for two years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/3 (0%) | 0/3 (0%) |
| Statins | — | 0/3 (0%) | 0/3 (0%) |
Males and females 30-60 years old, taking a statin, experiencing muscle pain, weakness, cramping and not at high risk for a cardiovascular event
| Age, Categorical(Participants) | Placebo | Statins | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 6 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo | Statins | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 3 | 2 | 5 |
| Race (NIH/OMB)(Participants) | Placebo | Statins | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 1 | 2 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Placebo | Statins | Total |
|---|---|---|---|
| United States | 3 | 3 | 6 |
This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Rockefeller University