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A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00384865
First Posted: October 6, 2006
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania
Results First Submitted: November 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension, Pulmonary
Interventions: Drug: Simvastatin
Drug: Aspirin
Drug: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aspirin 81 mg + Simvastatin 40 mg

Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months

Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months

Aspirin 81 mg + Placebo

Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months

Placebo: Placebo, taken orally, once a day for 6 months

Placebo + Simvastatin 40 mg

Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months

Placebo: Placebo, taken orally, once a day for 6 months

Placebo + Placebo Placebo: Placebo, taken orally, once a day for 6 months

Participant Flow:   Overall Study
    Aspirin 81 mg + Simvastatin 40 mg   Aspirin 81 mg + Placebo   Placebo + Simvastatin 40 mg   Placebo + Placebo
STARTED   16   16   16   16 
Completed Six Month Assessment   11   12   15   11 
COMPLETED   16   16   16   16 
NOT COMPLETED   0   0   0   0 



  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.
No text entered.

Reporting Groups
  Description
Aspirin 81 mg + Simvastatin 40 mg

Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months

Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months

Aspirin 81 mg + Placebo

Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months

Placebo: Placebo, taken orally, once a day for 6 months

Placebo + Simvastatin 40 mg

Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months

Placebo: Placebo, taken orally, once a day for 6 months

Placebo + Placebo Placebo: Placebo, taken orally, once a day for 6 months
Total Total of all reporting groups

Baseline Measures
   Aspirin 81 mg + Simvastatin 40 mg   Aspirin 81 mg + Placebo   Placebo + Simvastatin 40 mg   Placebo + Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   16   16   16   64 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.6  (16.6)   56.75  (13.2)   58.6  (11.7)   63.5  (14.2)   59.6  (13.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      11  68.8%      15  93.8%      15  93.8%      14  87.5%      55  85.9% 
Male      5  31.3%      1   6.3%      1   6.3%      2  12.5%      9  14.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      2  12.5%      1   6.3%      5  31.3%      0   0.0%      8  12.5% 
Not Hispanic or Latino      14  87.5%      15  93.8%      11  68.8%      16 100.0%      56  87.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   6.3%      0   0.0%      2  12.5%      3   4.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  12.5%      3  18.8%      3  18.8%      5  31.3%      13  20.3% 
White      13  81.3%      11  68.8%      12  75.0%      9  56.3%      45  70.3% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   6.3%      1   6.3%      1   6.3%      0   0.0%      3   4.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United States   16   16   16   16   64 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Distance Walked in Six Minutes   [ Time Frame: Measured at 6 months ]

2.  Secondary:   Time to Clinical Worsening Events (Number of Events)   [ Time Frame: Measured at 6 months ]

3.  Secondary:   Adverse Events   [ Time Frame: Measured at 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
  • The primary end point that should be used in early-stage clinical trials in PAH is uncertain.
  • We did not include invasive hemodynamic end points.
  • Early termination led to missing data for those active subjects in the trial at termination (n16).


  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: Steven Kawut
Organization: Penn
phone: 215-573-0258
e-mail: kawut@upenn.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00384865     History of Changes
Other Study ID Numbers: 458
R01HL082895-01 ( U.S. NIH Grant/Contract )
First Submitted: September 30, 2006
First Posted: October 6, 2006
Results First Submitted: November 16, 2016
Results First Posted: July 21, 2017
Last Update Posted: July 21, 2017