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Statin Therapy in Young Adult Survivors of Childhood Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01733953
First received: November 20, 2012
Last updated: August 19, 2016
Last verified: August 2016
Results First Received: April 11, 2016  
Study Type: 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
Conditions: Cardiovascular Disease
Childhood ALL
Childhood NHL
Interventions: Drug: Atorvastatin
Drug: Sugar Pill (Placebo)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Atorvastatin

6-Months Atorvastatin Therapy; 40mg oral, once daily

Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.

Sugar Pill (Placebo)

6-Months Placebo (sugar pill); oral, once daily

Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily


Participant Flow:   Overall Study
    Atorvastatin   Sugar Pill (Placebo)
STARTED   14   13 
COMPLETED   9   6 
NOT COMPLETED   5   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Atorvastatin

6-Months Atorvastatin Therapy; 40mg oral, once daily

Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.

Sugar Pill (Placebo)

6-Months Placebo (sugar pill); oral, once daily

Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily

Total Total of all reporting groups

Baseline Measures
   Atorvastatin   Sugar Pill (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   13   27 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   14   13   27 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.6  (5.7)   26.9  (6.9)   26.8  (6.2) 
Gender 
[Units: Participants]
     
Female   8   5   13 
Male   6   8   14 
Region of Enrollment 
[Units: Participants]
     
United States   14   13   27 


  Outcome Measures
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1.  Primary:   Change From Baseline in Brachial Artery Flow-Mediated Dilation at 6-months   [ Time Frame: Baseline and 6-Months ]

2.  Secondary:   Change From Baseline in Carotid Artery Compliance at 6-Months   [ Time Frame: Baseline and 6-Months ]

3.  Secondary:   Change From Baseline in Carotid Artery Distensibility at 6-Months   [ Time Frame: Baseline and 6-Months ]

4.  Secondary:   Change From Baseline in Pulse Wave Velocity at 6-Months   [ Time Frame: Baseline and 6-Months ]

5.  Secondary:   Change From Baseline in Augmentation Index at 6-Months   [ Time Frame: Baseline and 6-Months ]

6.  Secondary:   Change From Baseline in Carotid Intima-Media Thickness at 6-Months   [ Time Frame: Baseline and 6-Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Cameron Naughton
Organization: University of Minnesota
phone: 612-625-3623
e-mail: naug0009@umn.edu



Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01733953     History of Changes
Other Study ID Numbers: 1207M17202
Study First Received: November 20, 2012
Results First Received: April 11, 2016
Last Updated: August 19, 2016
Health Authority: United States: Institutional Review Board