Phase IIa: Safety, PK, & Tolerability of Sodium Nitrite in Patients With Peripheral Arterial Disease-SONIC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TheraVasc Inc.
ClinicalTrials.gov Identifier:
NCT01401517
First received: June 28, 2011
Last updated: May 29, 2014
Last verified: May 2014
Results First Received: May 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Peripheral Arterial Disease
Intervention: Drug: sodium nitrite

  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
Placebo sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose.
40 mg Sodium Nitrite

40 mg dose, BID

sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose.

80 mg Sodium Nitrite

80 mg dose, BID

sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose.


Participant Flow:   Overall Study
    Placebo     40 mg Sodium Nitrite     80 mg Sodium Nitrite  
STARTED     18     19     18  
COMPLETED     15     17     15  
NOT COMPLETED     3     2     3  



  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
Placebo Placebo twice each day for 11 weeks
40 mg Sodium Nitrite

40 mg dose, BID

40 mg sodium nitrite: 40 twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose.

80 mg Sodium Nitrite

80 mg dose, BID

sodium nitrite: 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose.

Total Total of all reporting groups

Baseline Measures
    Placebo     40 mg Sodium Nitrite     80 mg Sodium Nitrite     Total  
Number of Participants  
[units: participants]
  18     19     18     55  
Age  
[units: years]
Mean ± Standard Deviation
  64.9  ± 8.98     65.3  ± 8.86     67.9  ± 9.99     66.0  ± 9.21  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     6     11     4     21  
>=65 years     12     8     14     34  
Gender  
[units: participants]
       
Female     5     4     5     14  
Male     13     15     13     41  
Region of Enrollment  
[units: participants]
       
United States     18     19     18     55  



  Outcome Measures

1.  Primary:   Reporting of Adverse Events During 11 Week Treatment Period.   [ Time Frame: 11 weeks ]

2.  Secondary:   Assessment of Changes in Brachial Artery Flow-Mediated Dilation (FMD)at 10 Weeks From Baseline   [ Time Frame: 10 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Assessment of Changes in Walking Distance.   [ Time Frame: 10 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Assessment of Improvement of Quality of Life.   [ Time Frame: 10 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Tony Giordano
Organization: TheraVasc Inc.
phone: 318-349-3851
e-mail: tgiordano@theravasc.com


Publications:

Responsible Party: TheraVasc Inc.
ClinicalTrials.gov Identifier: NCT01401517     History of Changes
Other Study ID Numbers: TheraVasc-TV1001-002
Study First Received: June 28, 2011
Results First Received: May 29, 2014
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration