Trial record 1 of 1 for:
PPD 10558
Study of the Safety and Tolerability Associated With PPD10558 Versus Atorvastatin in Patients Previously Intolerant to Statins Due to Statin-associated Myalgia (SAM)
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| ClinicalTrials.gov Identifier: NCT01279590 |
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Recruitment Status :
Completed
First Posted : January 19, 2011
Last Update Posted : December 22, 2011
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Sponsor:
Furiex Pharmaceuticals, Inc
Information provided by (Responsible Party):
Furiex Pharmaceuticals, Inc
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myalgia Hypercholesterolemia Hyperlipidemia | Drug: PPD10558 Drug: Atorvastatin Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 282 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | March 2011 |
| Actual Primary Completion Date : | November 2011 |
| Actual Study Completion Date : | November 2011 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: PPD10558
Dosing will be forced-titrated as follows: 40 mg orally twice daily for 4 weeks and 80 mg orally twice daily for 8 weeks
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Drug: PPD10558
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 |
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Active Comparator: Atorvastatin
Dosing will be forced titrated as 40 mg orally once daily for 4 weeks, and 80 mg orally once daily for 8 weeks
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Drug: Atorvastatin
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 |
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Placebo Comparator: Placebo
Dosing will be 2 placebo capsules twice daily for 12 weeks
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Drug: Placebo
2 placebo capsules twice daily for 12 weeks |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279590
Locations
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Sponsors and Collaborators
Furiex Pharmaceuticals, Inc
| Responsible Party: | Furiex Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT01279590 |
| Other Study ID Numbers: |
PPD10558-010 |
| First Posted: | January 19, 2011 Key Record Dates |
| Last Update Posted: | December 22, 2011 |
| Last Verified: | December 2011 |
Keywords provided by Furiex Pharmaceuticals, Inc:
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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 |
Additional relevant MeSH terms:
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Myalgia Hypercholesterolemia Hyperlipidemias Hyperlipoproteinemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases |
Musculoskeletal Pain Pain Neurologic Manifestations Atorvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |