Effect of Simvastatin Treatment on Vaso-occlusive Pain in Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT01702246|
Recruitment Status : Completed
First Posted : October 8, 2012
Results First Posted : December 19, 2016
Last Update Posted : December 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Drug: Simvastatin||Phase 1 Phase 2|
Sickle cell disease (SCD) is characterized by recurrent vaso-occlusive episodes and a chronic inflammatory state leading to progressive multi-organ injury. The pathophysiology of SCD is related to endothelial dysfunction driven largely by impaired nitric oxide (NO) homeostasis and chronic inflammation. Through multiple mechanisms, including upregulation of NO, statins have been shown to confer protection from endothelial injury, independent of their cholesterol-lowering properties.
By inhibiting inflammation and several common pathways leading to vascular damage,simvastatin may help prevent the acute and chronic complications of SCD. The objective of this study is to determine whether our preliminary results showing simvastatin-associated reductions in plasma markers of vascular injury will translate into a reduction in vaso-occlusive pain episodes in patients with SCD. A web-based, smartphone-accessible electronic pain diary will be used to monitor frequency and intensity of vaso-occlusive pain in SCD patients treated with a single daily dose of simvastatin.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Simvastatin Treatment Effects on Vaso-occlusive Pain in Sickle Cell Disease|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||June 2015|
Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months
40 mg, orally, once daily for 3 months
Other Name: Zocor
- Change in Frequency of Vaso-occlusive Pain Events, Before and After Treatment With Simvastatin [ Time Frame: Baseline and 3 months ]The effect of simvastatin treatment will be assessed by measuring the difference from baseline in the mean frequency (and intensity) of vaso-occlusive pain events, after treatment with simvastatin. Pain rate (proportion of pain days) was defined as the number of days reported with sickle cell disease-related pain divided by the number of daily pain diaries completed.
- Change in Plasma High Sensitivity C-reactive Protein [ Time Frame: Baseline and 3 months ]Mean difference in plasma high sensitivity C-reactive protein level, before and after treatment with simvastatin
- Change From Baseline in Total Cholesterol Level After Treatment With Simvastatin [ Time Frame: Baseline and 3 months ]
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): NCT01702246
|United States, California|
|Children's Hospital and Research Center Oakland|
|Oakland, California, United States, 94609|
|Principal Investigator:||Carolyn Hoppe, MD||UCSF Benioff Children’s Hospital Oakland|