Simvastatin (Zocor) Therapy in Sickle Cell Disease

Completed · Phase 1/Phase 2

Conditions studied: Sickle Cell Disease

In brief

Recent clinical and experimental data indicate that statins have effects beyond cholesterol lowering that may be beneficial in sickle cell disease by protecting the vascular endothelium. Statins have been shown to attenuate endothelial dysfunction through their anti-inflammatory, anti-oxidant and anti-thrombotic properties. This phase I/II dose-escalating trial is designed to assess the safety and potential clinical efficacy of oral simvastatin (Zocor)in adolescents and adults with sickle cell disease (SCD).

Key facts

Study ID

NCT00508027

Run by

UCSF Benioff Children's Hospital Oakland

People needed

42

Starts

2007-06-01

Expected to finish

2011-12-01

Last updated by the study team

2013-09-17

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Established diagnosis of sickle cell disease (HbSS, SC or Sβ-thalassemia)
• Age greater than or equal to thirteen years
• Weight greater than or equal to 35 kg

You may not qualify if…

• Renal dysfunction (Serum Creatinine > 1.5 UNL)
• Hepatic dysfunction (ALT > 2X UNL)
• Pretreatment total cholesterol < 100 mg/dL or triglycerides < 30 mg/dL
• Pretreatment baseline creatine kinase >1X UNL (215 U/L)
• Pregnancy/lactation
• RBC transfusion in the last 30 days
• Vaso-Occlusive Event needing hospitalization in the past 30 days
• Treatment with any statin drugs within the past 30 days
• Treatment with drugs having known metabolic interactions with statin drugs (e.g. cytochrome P450 3A4 metabolism), including ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, azithromycin, niacin (nicotinic acid), digoxin, coumadin, sildenafil or amiodarone within the past 30 days
• Treatment (past or present) with amiodarone
• Musculoskeletal disorder associated with an elevated creatine kinase level
• Past or present history of substance abuse (alcohol, cocaine, amphetamines, heroin, PCP)
• Allergy to statins

Where it is running

• Children's Hospital and Research Center Oakland — Oakland, California, United States

Full record on ClinicalTrials.gov

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