Sildenafil Therapy for Pulmonary Hypertension and Sickle Cell Disease
This study has been terminated.
(Subjects on drug were more likely to have severe pain crises requiring hospitalization.)
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00492531
First received: June 26, 2007
Last updated: June 3, 2011
Last verified: June 2011
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Results First Received: April 28, 2011
Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment |
Conditions: |
Sickle Cell Disease Pulmonary Hypertension |
Interventions: |
Drug: Sildenafil Drug: Placebo |
Participant Flow
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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Subjects with Sickle cell hemoglobinopathy were recruited from 10 centers(9 in United States and 1 in United Kingdom) |
Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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No text entered. |
Reporting Groups
Description | |
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Sildenafil | Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated). |
Placebo | Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated). |
Participant Flow: Overall Study
Sildenafil | Placebo | |
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STARTED | 37 | 37 |
COMPLETED | 15 [1] | 14 [2] |
NOT COMPLETED | 22 | 23 |
Withdrawn(More than one reason selected) | 22 | 23 |
[1] | Of 15 subjects who completed study, 13 were enrolled in Open label. |
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[2] | Of 14 subjects who completed study, 13 were enrolled in Open label. |
Baseline Characteristics
Reporting Groups
Description | |
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Sildenafil | Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated). |
Placebo | Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated). |
Baseline Measures
Sildenafil | Placebo | Total | |
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Number of Participants
[units: participants] |
37 | 37 | 74 |
Age
[units: years] Mean ± Standard Deviation |
47 ± 13 | 44 ± 14 | 45 ± 13 |
Gender
[units: participants] |
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Female | 23 | 23 | 46 |
Male | 14 | 14 | 28 |
Ethnicity (NIH/OMB)
[units: Participants] |
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Not Hispanic or Latino | 32 | 37 | 69 |
Unknown or Not Reported | 5 | 0 | 5 |
Race (NIH/OMB)
[units: participants] |
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Black or African American | 36 | 37 | 73 |
Unknown or Not Reported | 1 | 0 | 1 |
6 minute walk
[1] [units: Meters] Mean ± Standard Deviation |
381 ± 75 | 386 ± 75 | 383 ± 75 |
Tricuspid regurgitant jet velocity (TRV)
[2] [units: m/s] Mean ± Standard Deviation |
3.0 ± 0.5 | 3.0 ± 0.3 | 3.0 ± 0.3 |
[1] | The distance walked in six minute was used to assess the exercise capacity of the patient at baseline. |
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[2] | Tricuspid regurgitant jet velocity was measured by transthoracic Doppler Echocardiography. |
Outcome Measures
1. Primary: | Change in Exercise Capacity as Assessed by 6 Minute Walk. [ Time Frame: Baseline to week 16/Imputed last visit. ] |
2. Secondary: | Change From Baseline in Pulmonary Hypertension at Week 16 as Assessed by Tricuspid Regurgitant Jet Velocity [ Time Frame: 16 weeks ] |
3. Secondary: | Borg Dyspnea Score [ Time Frame: baseline to 16 weeks ] |
4. Secondary: | Brain Natriuretic Peptide(BNP)Levels. [ Time Frame: 16 weeks ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
Publications:
Publications automatically indexed to this study:
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. |
Limitations and Caveats
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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As a result of early termination due to safety findings, the study was underpowered to assess the effects of sildenafil therapy on the predetermined efficacy endpoints. |
Results Point of Contact:
Name/Title: Mark Gladwin
Organization: Professor of Medicine: Chief, Pulmonary, Allergy and Critical Care Medicine: Director, Hemostasis and Vascular Biology Research Institute; University of Pittsburgh School of Medicine
phone: 412-692-2117
e-mail: gladwinmt@upmc.edu
Organization: Professor of Medicine: Chief, Pulmonary, Allergy and Critical Care Medicine: Director, Hemostasis and Vascular Biology Research Institute; University of Pittsburgh School of Medicine
phone: 412-692-2117
e-mail: gladwinmt@upmc.edu
Publications:
Publications automatically indexed to this study:
Responsible Party: | Mark T. Gladwin, M.D.Professor of Medicine: Chief, Pulmonary, Allergy and Critical CRE Medicine: Director, Hemostasis and Vascular Biology Research Institute; University of Pittsburgh School of Medicine, Hemostasis and Vascular Biology Research Institute; University of Pittsburgh School of Medicine |
ClinicalTrials.gov Identifier: | NCT00492531 History of Changes |
Other Study ID Numbers: | 070177, 07-H-0177 |
Study First Received: | June 26, 2007 |
Results First Received: | April 28, 2011 |
Last Updated: | June 3, 2011 |
Health Authority: | United States: Federal Government United States: Food and Drug Administration |