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A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).

This study has been completed.
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
Roham T. Zamanian, Stanford University
ClinicalTrials.gov Identifier:
NCT01305252
First received: November 2, 2010
Last updated: April 27, 2017
Last verified: April 2017
Results First Received: November 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Condition: Hypertension, Pulmonary
Interventions: Drug: treprostinil inhalations
Drug: tadalafil

  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
Tadalafil Alone

tadalafil 40mg QD

tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated

Tadalafil and Treprostinil Inhalations

inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.

tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated


Participant Flow:   Overall Study
    Tadalafil Alone   Tadalafil and Treprostinil Inhalations
STARTED   10   11 
COMPLETED   9   11 
NOT COMPLETED   1   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
Tadalafil Alone

tadalafil 40mg QD

tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated

Tadalafil and Treprostinil Inhalations

inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.

tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated

Total Total of all reporting groups

Baseline Measures
   Tadalafil Alone   Tadalafil and Treprostinil Inhalations   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   11   21 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      11 100.0%      21 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.6  (11.4)   52.1  (9.7)   51.9  (10.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   7   9   16 
Male   3   2   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Right Ventricular Ejection Fraction   [ Time Frame: Basline and 24 weeks ]

2.  Secondary:   6 Minute Walk Distance   [ Time Frame: Baseline and 24 weeks ]

3.  Secondary:   N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)   [ Time Frame: Baseline and 24 weeks ]

4.  Secondary:   Change in NYHA/WHO Class   [ Time Frame: Baseline and 48 week ]

5.  Secondary:   B-type Natriuretic Peptide (BNP)   [ Time Frame: Baseline and 24 weeks ]


  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
Limitations: small,2 center study,Placebo Un-blinded,Limited event rates/Time to clinical worsening and harmonization of measures.


  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: Roham Zamanian, MD, FCCP
Organization: Stanford University School of Medicine
phone: 650- 725-5495
e-mail: zamanian@stanford.edu



Responsible Party: Roham T. Zamanian, Stanford University
ClinicalTrials.gov Identifier: NCT01305252     History of Changes
Other Study ID Numbers: SU-07152010-6565
IRB protocol # 18305
Study First Received: November 2, 2010
Results First Received: November 21, 2016
Last Updated: April 27, 2017