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Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00454207
First received: March 28, 2007
Last updated: August 19, 2013
Last verified: August 2010
Results First Received: February 18, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Hypertension
Intervention: Drug: sildenafil citrate (UK-92,480)

  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
Eight centers in Japan

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Twenty-one pulmonary arterial hypertension patients who have never received sildenafil therapy entered the study from Part I period and could continue to study part II period. Twenty-three patients who were continuously using sildenafil entered the study from Part II period.

Reporting Groups
  Description
Sildenafil: Participant Who Entered the Study From Part I Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Sildenafil: Participants Who Entered the Study From Part II Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).

Participant Flow:   Overall Study
    Sildenafil: Participant Who Entered the Study From Part I     Sildenafil: Participants Who Entered the Study From Part II  
STARTED     21     23  
COMPLETED     17 [1]   21  
NOT COMPLETED     4     2  
Adverse Event                 3                 1  
Lack of Efficacy                 1                 0  
Protocol Violation                 0                 1  
[1] 19 participants completed Part I period. 17 of 19 participants continued from part I into Part II.



  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
Sildenafil: Participant Who Entered the Study From Part I Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Sildenafil: Participants Who Entered the Study From Part II Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).
Total Total of all reporting groups

Baseline Measures
    Sildenafil: Participant Who Entered the Study From Part I     Sildenafil: Participants Who Entered the Study From Part II     Total  
Number of Participants  
[units: participants]
  21     23     44  
Age  
[units: participants]
     
<=18 years     0     1     1  
Between 18 and 65 years     19     20     39  
>=65 years     2     2     4  
Gender  
[units: participants]
     
Female     17     21     38  
Male     4     2     6  
Region of Enrollment  
[units: participants]
     
Japan     21     23     44  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

2.  Primary:   Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

3.  Primary:   Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

4.  Primary:   Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, week 12 ]

5.  Secondary:   Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 8 ]

6.  Secondary:   Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:   Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

8.  Secondary:   Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

9.  Secondary:   Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

10.  Secondary:   Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

11.  Secondary:   Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

12.  Secondary:   Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

13.  Secondary:   Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

14.  Secondary:   Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

15.  Secondary:   Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

16.  Secondary:   Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

17.  Secondary:   Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: baseline, Week 12 ]

18.  Secondary:   Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

19.  Secondary:   Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

20.  Secondary:   Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: baseline, Week 12 ]

21.  Secondary:   Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

22.  Secondary:   Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 12 ]

23.  Secondary:   Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 8, Week 12 ]

24.  Secondary:   Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I   [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]

25.  Secondary:   Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II   [ Time Frame: Baseline, Week 12 ]

26.  Secondary:   Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II   [ Time Frame: Baseline, Week 12 ]

27.  Secondary:   Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II   [ Time Frame: Baseline, Week 12 ]

28.  Secondary:   Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II   [ Time Frame: Baseline, Week 12 ]

29.  Secondary:   Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320   [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing ]

30.  Secondary:   Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320   [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing ]

31.  Secondary:   The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320   [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing ]

32.  Secondary:   The Average Plasma Concentration (Css,av) of Sildenafil at Steady State   [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing ]

33.  Secondary:   The Average Plasma Trough Concentration (Ctrough) of Sildenafil   [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing ]

34.  Secondary:   Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)   [ Time Frame: Baseline up to 1.3 years ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00454207     History of Changes
Other Study ID Numbers: A1481252, JapicCTI-070381
Study First Received: March 28, 2007
Results First Received: February 18, 2010
Last Updated: August 19, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare