Know Cancer

or
forgot password

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


Phase 2
40 Years
N/A
Not Enrolling
Both
Myalgia, Hypercholesterolemia, Hyperlipidemia

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Incidence of stopping treatment with double-blinded study drug due to statin-associated myalgia.

Outcome Description:

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.

Outcome Time Frame:

Up to week 12

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PPD10558-010

NCT ID:

NCT01279590

Start Date:

March 2011

Completion Date:

November 2011

Related Keywords:

  • Myalgia
  • Hypercholesterolemia
  • Hyperlipidemia
  • 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
  • Hypercholesterolemia
  • Hyperlipidemias
  • Hyperlipoproteinemia Type II

Name

Location

Furiex research siteAnniston, Alabama  36207
Furiex research sitePhoenix, Arizona  85018
Furiex research siteHuntington Park, California  90255
Furiex research siteColorado Springs, Colorado  80907
Furiex research siteHartford, Connecticut  06102
Furiex research siteBoynton Beach, Florida  33472
Furiex research siteHonolulu, Hawaii  96814
Furiex Research siteBoise, Idaho  83704
Furiex research siteChicago, Illinois  60616
Furiex research siteMission, Kansas  66202
Furiex research siteMadisonville, Kentucky  42431
Furiex research siteCovington, Louisiana  70433
Furiex research siteAuburn, Maine  04210
Furiex research siteOxon Hill, Maryland  20745
Furiex research siteBay City, Michigan  48706
Furiex research siteSt. Louis, Missouri  63117
Furiex research siteBillings, Montana  59101
Furiex research siteOmaha, Nebraska  68144
Furiex research siteGreat Neck, New York  11023
Furiex research siteAsheville, North Carolina  28803
Furiex research siteCarlisle, Ohio  45005
Furiex research siteAltoona, Pennsylvania  16602
Furiex research siteCumberland, Rhode Island  02864
Furiex research siteAnderson, South Carolina  29621
Furiex research siteBristol, Tennessee  37620
Furiex research siteTomball, Texas  77375
Furiex research siteSalt Lake City, Utah  84124
Furiex research siteNorfolk, Virginia  23502
FuriexSpokane, Washington  99208