MyalgiaPhase 2NCT01279590

Study of the Safety and Tolerability Associated With PPD10558 Versus Atorvastatin in Patients Previously Intolerant to Statins Due to Statin-associated Myalgia (SAM)

A Phase 2 study testing PPD10558 and Atorvastatin in people with Myalgia and Hypercholesterolemia, run by Furiex Pharmaceuticals, Inc at 67 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to assess the incidence of statin-associated myalgia (SAM) with treatment with PPD10558 versus atorvastatin in patients previously intolerant to statins. To assess the safety and tolerability of PPD10558 compared to atorvastatin in patients previously intolerant to statins. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Myalgia, Hypercholesterolemia, Hyperlipidemia
What is being tested?: PPD10558 and Atorvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 282 participants
Where: 67 sitesUnited States
Study dates: Mar 2011to Nov 2011
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

diagnosis of primary hypercholesterolemia (heterozygous familial and nonfamilial) Fredrickson types IIa or IIb.
history of statin-associated myalgia, as defined by being unable to tolerate two previous statins due to muscle pain, aches, weakness, or cramping that begins or increases during statin therapy and stops when statin therapy is discontinued. History of statin-associated myalgia will be captured on the historical questionnaire on statin-associated myalgia.
LDL-C > 110 mg/dL and triglycerides < 500 mg/dL at Prescreening.
prescreening hemoglobin value of ≥10 g/dL for females and ≥12 g/dL.
patient agrees to stop all other antihyperlipidemic agents (including but not limited to niacin, probucol, ezetimibe, fibrates and derivatives, bile acid-sequestering agents, other 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase inhibitors, fish oils, flaxseed oil, and red yeast rice).
patient agrees to stop all Coenzyme Q10 supplements.
if taking other nonexcluded medications, patients must be on a stable dose for 4 weeks before screening.

Who cannot join

history of chronic pain and currently experiences chronic pain unrelated to statins that requires chronic use of pain medications, has been diagnosed with fibromyalgia or has severe neuropathic pain.
requires the chronic use of pain medications, including acetaminophen, non-steroidal anti-inflammatory medications, narcotics, and other analgesics.
vitamin D insufficiency (current insufficiency is defined as Vitamin D3 < 20 ng/mL [50 nmol/L] measured at Prescreening.
hypothyroidism or abnormal thyroid function test as confirmed by thyroid-stimulating hormone ≥ 5 mcIU/mL and free thyroxine (T4) < 0.7 ng/dL at Prescreening
history of rhabdomyolysis (defined as evidence of organ damage with creatinine kinase(CK) > 10,000 IU/L).
history of liver disease

Show all 15Show fewer

history of significant renal dysfunction as defined by serum creatinine clearance < 30 mL/min
Nephrotic-range proteinuria.
HbA1C >9% at Prescreening.
CK levels >5 times the upper limit of normal at Prescreening.
congestive heart failure, even with current therapy
has had myocardial infarction, cardiac intervention, cerebrovascular accident/stroke or transient ischemic attack less than 6 months prior to prescreening.
patient is pregnant (confirmed by laboratory testing) or breastfeeding.
history of cancer (other than basal cell and/or squamous cell carcinoma of the skin and/or Stage I squamous cell carcinoma of the cervix) that has not been in full remission for at least 1 year before Screening.
patient has positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus types 1 or 2 at Prescreening.

Trial locations and contacts

67 sites in 1 country.

City, postcode or hospital

67 sites in 1 country

United States67 sites

Furiex research site
Altoona, Pennsylvania, 16602
Furiex research site
Anderson, South Carolina, 29621
Furiex research site
Anniston, Alabama, 36207
Furiex research site
Asheville, North Carolina, 28803
Furiex research site
Auburn, Maine, 04210
Furiex research site
Bay City, Michigan, 48706
Furiex research site
Billings, Montana, 59101
Furiex Research site
Boise, Idaho, 83704
Furiex research site
Boynton Beach, Florida, 33472
Furiex research site
Bristol, Tennessee, 37620
Furiex research site
Butte, Montana, 59701
Furiex research site
Carlisle, Ohio, 45005
Furiex research site
Cary, North Carolina, 27518
Furiex research site
Charlotte, North Carolina, 28209
Furiex research site
Chicago, Illinois, 60616
Furiex research site
Cincinnati, Ohio, 45236
Furiex research site
Colorado Springs, Colorado, 80907
Furiex research site
Columbus, Ohio, 43213
Furiex research site
Coral Gables, Florida, 33134
Furiex research site
Covington, Louisiana, 70433
Furiex research site
Cumberland, Rhode Island, 02864
Furiex research site
Deerfield Beach, Florida, 33441
Furiex research site
East Providence, Rhode Island, 02914
Furiex research site
Fort Lauderdale, Florida, 33308
Furiex research site
Gainesville, Florida, 32605
Furiex research site
Golden, Colorado, 80401
Furiex research site
Great Neck, New York, 11023
Furiex research site
Greenville, South Carolina, 29605
Furiex research site
Greer, South Carolina, 29651
Furiex research site
Harrisburg, North Carolina, 28075
Furiex research site
Hartford, Connecticut, 06102
Furiex research site
Hickory, North Carolina, 28601
Furiex research site
Hickory, North Carolina, 28602
Furiex research site
High Point, North Carolina, 27262
Furiex research site
Honolulu, Hawaii, 96814
Furiex research site
Huntington Park, California, 90255
Furiex research site
Johnstown, Pennsylvania, 15905
Furiex research site
Kettering, Ohio, 45429
Furiex research site
Long Beach, California, 90806
Furiex research site
Madisonville, Kentucky, 42431
Furiex research site
Mission, Kansas, 66202
Furiex research site
Missoula, Montana, 59808
Furiex research site
Mt. Pleasant, South Carolina, 29464
Furiex research site
Nampa, Idaho, 83686
Furiex research site
Norfolk, Virginia, 23502
Furiex research site
Omaha, Nebraska, 68144
Furiex research site
Opa-locka, Florida, 33054
Furiex research site
Oxon Hill, Maryland, 20745
Furiex research site
Pawleys Island, South Carolina, 29585
Furiex research site
Pembroke, Florida, 33024
Furiex research site
Pembroke, Florida, 33028
Furiex research site
Phoenix, Arizona, 85018
Furiex research site
Phoenix, Arizona, 85023
Furiex research site
Pismo Beach, California, 93449
Furiex research site
Raleigh, North Carolina, 27609
Furiex research site
Raleigh, North Carolina, 27612
Furiex research site
Richmond, Virginia, 23294
Furiex research site
Salt Lake City, Utah, 84124
Furiex research site
San Diego, California, 92103
Furiex research site
Sanford, Florida, 32771
Furiex
Spokane, Washington, 99208
Furiex research site
Springfield, Ohio, 45505
Furiex research site
St Louis, Missouri, 63117
Furiex research site
Tomball, Texas, 77375
Furiex research site
West Lake Village, California, 91361
Furiex research site
West Palm Beach, Florida, 33401
Furiex research site
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Double-blind, Randomized, Placebo-controlled and Active-comparator-controlled Phase 2b Study to Evaluate Statin-associated Myalgia Incidence, Lipid Profile Effect, and Safety and Tolerability Associated With PPD10558 Versus Atorvastatin in Patients With Primary Hypercholesterolemia, Fredrickson IIa or IIb, Who Have Discontinued Two or More Prior Statin Therapies Due to Statin-associated Myalgia

The purpose of this study is to assess the incidence of statin-associated myalgia (SAM) with treatment with PPD10558 versus atorvastatin in patients previously intolerant to statins.

To assess the safety and tolerability of PPD10558 compared to atorvastatin in patients previously intolerant to statins.

Conditions: Myalgia, Hypercholesterolemia, Hyperlipidemia
Being tested: PPD10558, Atorvastatin, Placebo
Keywords: Hyperlipidemia, Dyslipidemia, Metabolic diseases, Lipid metabolism disorders, Hyperlipoproteinemia Type IIa, Hyperlipoproteinemia Type IIb, Hypercholesterolemia, Autosomal Dominant, Hypercholesterolemia, Autosomal Dominant, Type B, Frederickson Type IIa, Frederickson Type IIb Hyperlipidemia
Medical subject headings: Myalgia, Hypercholesterolemia, Hyperlipidemias, Dyslipidemias, Metabolic Diseases, Lipid Metabolism Disorders, Hyperlipoproteinemia Type II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PPD10558Drug
PPD10558 40 mg capsule and matching placebo capsule twice a day for 4 weeks, then
PPD10558 80 mg (two 40 mg capsules) twice a day for 8 weeks
AtorvastatinDrug
Atorvastatin 40 mg capsule and matching placebo capsule in the morning and 2 placebo capsules in the evening for 4 weeks, then
Atorvastatin 80 mg (two 40 mg capsules) in the morning and 2 placebo capsules in the evening for 8 weeks
PlaceboDrug
2 placebo capsules twice daily for 12 weeks

Study groups in NCT01279590
Study group	Role	What they receive
PPD10558	Experimental	Dosing will be forced-titrated as follows: 40 mg orally twice daily for 4 weeks and 80 mg orally twice daily for 8 weeks Receives: Drug: PPD10558
Atorvastatin	Active comparator	Dosing will be forced titrated as 40 mg orally once daily for 4 weeks, and 80 mg orally once daily for 8 weeks Receives: Drug: Atorvastatin
Placebo	Placebo comparator	Dosing will be 2 placebo capsules twice daily for 12 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of stopping treatment with double-blinded study drug due to statin-associated myalgia.
Patients who withdraw from participating in the study prior to Week 12 and who also stop study drug due to SAM, or patients who become lost to follow up will be considered to have stopped treatment with double-blinded study drug.
Measured: Up to week 12

Secondary outcomes (7)

Change from Baseline in fasting lipid profile components (low density lipoprotein-cholesterol(LDL-C), high density lipoprotein-cholesterol(HDL-C), triglyceride(TG), total cholesterol(TC), Apolipoprotein B(ApoB), HDL-TG, LDL/HDL ratio and TC/HDL ratio)
Measured: Up to week 12
Change from baseline in muscle strength measurements (Sit-to-stand(STS) performance and hand grip strength by Jamar Hydraulic Hand Dynamometer)
Measured: Up to week 12
Frequency of pain rescue medication
Measured: Up to week 12
Change from Baseline in inflammatory markers (Tumor necrosis factor α (TNF-α), C-reactive protein (CRP), and lipoprotein-associated phospholipase A2 (Lp-PLA2))
Measured: Up to week 12
Change in patients' functional health and well-being as measured by the Short Form-36v2 Health Survey (SF-36)
Measured: Up to week 12
Time to onset of statin -associated myalgia (SAM)
Measured: Up to week 12
Time to stopping treatment with study drug due to SAM
Measured: Up to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Nov 2011

First posted19 Jan 2011 (estimated)
Study startMar 2011
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 282 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01279590
Sponsor's protocol ID: PPD10558-010
Status last verified: Dec 2011
First submitted: 18 Jan 2011
Last updated: 22 Dec 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Placebo-controlled and Active-comparator-controlled Phase 2b Study to Evaluate Statin-associated Myalgia Incidence, Lipid Profile Effect, and Safety and Tolerability Associated With PPD10558 Versus Atorvastatin in Patients With Primary Hypercholesterolemia, Fredrickson IIa or IIb, Who Have Discontinued Two or More Prior Statin Therapies Due to Statin-associated Myalgia
ClinicalTrials.gov ID: NCT01279590
Acronym / sponsor ID: PPD10558-010
Conditions: Myalgia, Hypercholesterolemia, Hyperlipidemia
Keywords: Hyperlipidemia, Dyslipidemia, Metabolic diseases, Lipid metabolism disorders, Hyperlipoproteinemia Type IIa, Hyperlipoproteinemia Type IIb, Hypercholesterolemia, Autosomal Dominant, Hypercholesterolemia, Autosomal Dominant, Type B
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 282 participants (actual)
Lead sponsor: Furiex Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 19 Jan 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the incidence of statin-associated myalgia (SAM) with treatment with PPD10558 versus atorvastatin in patients previously intolerant to statins.

To assess the safety and tolerability of PPD10558 compared to atorvastatin in patients previously intolerant to statins.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
PPD10558	Experimental	Drug: PPD10558Dosing will be forced-titrated as follows: 40 mg orally twice daily for 4 weeks and 80 mg orally twice daily for 8 weeks
Atorvastatin	Active comparator	Drug: AtorvastatinDosing will be forced titrated as 40 mg orally once daily for 4 weeks, and 80 mg orally once daily for 8 weeks
Placebo	Placebo comparator	Drug: PlaceboDosing will be 2 placebo capsules twice daily for 12 weeks

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

diagnosis of primary hypercholesterolemia (heterozygous familial and nonfamilial) Fredrickson types IIa or IIb.
history of statin-associated myalgia, as defined by being unable to tolerate two previous statins due to muscle pain, aches, weakness, or cramping that begins or increases during statin therapy and stops when statin therapy is discontinued. History of statin-associated myalgia will be captured on the historical questionnaire on statin-associated myalgia.
LDL-C > 110 mg/dL and triglycerides < 500 mg/dL at Prescreening.
prescreening hemoglobin value of ≥10 g/dL for females and ≥12 g/dL.
patient agrees to stop all other antihyperlipidemic agents (including but not limited to niacin, probucol, ezetimibe, fibrates and derivatives, bile acid-sequestering agents, other 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase inhibitors, fish oils, flaxseed oil, and red yeast rice).

Key exclusion criteria (15 listed)

history of chronic pain and currently experiences chronic pain unrelated to statins that requires chronic use of pain medications, has been diagnosed with fibromyalgia or has severe neuropathic pain.
requires the chronic use of pain medications, including acetaminophen, non-steroidal anti-inflammatory medications, narcotics, and other analgesics.
vitamin D insufficiency (current insufficiency is defined as Vitamin D3 < 20 ng/mL [50 nmol/L] measured at Prescreening.
hypothyroidism or abnormal thyroid function test as confirmed by thyroid-stimulating hormone ≥ 5 mcIU/mL and free thyroxine (T4) < 0.7 ng/dL at Prescreening
history of rhabdomyolysis (defined as evidence of organ damage with creatinine kinase(CK) > 10,000 IU/L).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PPD10558PPD10558 40 mg capsule and matching placebo capsule twice a day for 4 weeks, then PPD10558 80 mg (two 40 mg capsules) twice a day for 8 weeks	Drug	PPD10558
AtorvastatinAtorvastatin 40 mg capsule and matching placebo capsule in the morning and 2 placebo capsules in the evening for 4 weeks, then Atorvastatin 80 mg (two 40 mg capsules) in the morning and 2 placebo capsules in the evening for 8 weeks	Drug	Atorvastatin
Placebo2 placebo capsules twice daily for 12 weeks	Drug	Placebo

Primary outcome

Incidence of stopping treatment with double-blinded study drug due to statin-associated myalgia.
Time frame: Up to week 12
Patients who withdraw from participating in the study prior to Week 12 and who also stop study drug due to SAM, or patients who become lost to follow up will be considered to have stopped treatment with double-blinded study drug.

7 secondary outcomes

Change from Baseline in fasting lipid profile components (low density lipoprotein-cholesterol(LDL-C), high density lipoprotein-cholesterol(HDL-C), triglyceride(TG), total cholesterol(TC), Apolipoprotein B(ApoB), HDL-TG, LDL/HDL ratio and TC/HDL ratio)
Time frame: Up to week 12
Change from baseline in muscle strength measurements (Sit-to-stand(STS) performance and hand grip strength by Jamar Hydraulic Hand Dynamometer)
Time frame: Up to week 12
Frequency of pain rescue medication
Time frame: Up to week 12
Change from Baseline in inflammatory markers (Tumor necrosis factor α (TNF-α), C-reactive protein (CRP), and lipoprotein-associated phospholipase A2 (Lp-PLA2))
Time frame: Up to week 12
Change in patients' functional health and well-being as measured by the Short Form-36v2 Health Survey (SF-36)
Time frame: Up to week 12
Time to onset of statin -associated myalgia (SAM)
Time frame: Up to week 12
Time to stopping treatment with study drug due to SAM
Time frame: Up to week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2011.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

67 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PPD10558 and Atorvastatin in people with Myalgia and Hypercholesterolemia, run by Furiex Pharmaceuticals, Inc at 67 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of stopping treatment with double-blinded study drug due to statin-associated myalgia. (time frame: Up to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01279590.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2011.