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Trial record 89 of 696 for:    sickle cell disease

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
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Carolyn Hoppe, UCSF Benioff Children’s Hospital Oakland

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sickle Cell Disease
Intervention Drug: Simvastatin
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Simvastatin
Hide Arm/Group Description

Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months

Simvastatin: 40 mg, orally, once daily for 3 months

Period Title: Overall Study
Started 24
Completed 19
Not Completed 5
Reason Not Completed
Lost to Follow-up             2
Withdrawal by Subject             2
Physician Decision             1
Arm/Group Title Simvastatin
Hide Arm/Group Description

Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months

Simvastatin: 40 mg, orally, once daily for 3 months

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
11
  57.9%
Between 18 and 65 years
8
  42.1%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
18.5  (6.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
13
  68.4%
Male
6
  31.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
18
  94.7%
White
1
   5.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Receiving hydroxyurea (HU) therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants
10
1.Primary Outcome
Title Change in Frequency of Vaso-occlusive Pain Events, Before and After Treatment With Simvastatin
Hide Description 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.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Simvastatin
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prior to treatment with simvastatin
after treatment with simvastatin: 40 mg, orally, once daily for 3 months
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: proportion of pain days
0.2365  (0.21) 0.1311  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline, Simvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments Wilcoxon matched pairs signed rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Change in Plasma High Sensitivity C-reactive Protein
Hide Description Mean difference in plasma high sensitivity C-reactive protein level, before and after treatment with simvastatin
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Simvastatin
Hide Arm/Group Description:
prior to treatment with simvastatin
after treatment with simvastatin: 40 mg, orally, once daily for 3 months
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: mg/mL
7.2  (11) 2.989  (4.169)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline, Simvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Total Cholesterol Level After Treatment With Simvastatin
Hide Description [Not Specified]
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
change in baseline cholesterol level from baseline, after treatment with simvastatin
Arm/Group Title Baseline Cholesterol Simvastatin Treatment
Hide Arm/Group Description:
mean cholesterol level (mmol/L) prior to treatment with simvastatin
after treatment with simvastatin: 40 mg, orally, once daily for 3 months
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: mmol/L
124  (27) 101  (17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Cholesterol, Simvastatin Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Safety data were collected on each participant during the treatment period (3 months) and at 1 month follow up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Simvastatin
Hide Arm/Group Description

Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months

Simvastatin: 40 mg, orally, once daily for 3 months

All-Cause Mortality
Simvastatin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Simvastatin
Affected / at Risk (%) # Events
Total   5/19 (26.32%)    
Blood and lymphatic system disorders   
sickle cell vaso-occlusive pain crisis  [1]  4/19 (21.05%) 
hyperhemolysis  [2]  1/19 (5.26%) 
Indicates events were collected by systematic assessment
[1]
Four participants were hospitalized for sickle cell related vaso-occlusive pain crisis (expected SAE)
[2]
One participant was hospitalized for sickle cell related hyperhemolytic event (unrelated to study drug)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Simvastatin
Affected / at Risk (%) # Events
Total   1/19 (5.26%)    
Skin and subcutaneous tissue disorders   
facial rash   1/19 (5.26%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Carolyn Hoppe
Organization: UCSF Benioff Children's Hospital Oakland
Phone: (510)428-3193
EMail: choppe@mail.cho.org
Layout table for additonal information
Responsible Party: Carolyn Hoppe, UCSF Benioff Children’s Hospital Oakland
ClinicalTrials.gov Identifier: NCT01702246     History of Changes
Other Study ID Numbers: DDCF-ICRA-2011
First Submitted: October 4, 2012
First Posted: October 8, 2012
Results First Submitted: January 15, 2016
Results First Posted: December 19, 2016
Last Update Posted: December 19, 2016