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A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Palo Alto, California, 94304 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Children Pulmonary Arterial Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-17 year
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects aged from 1 to 17 years old and weighing >= 8 kg with a mean
pulmonary artery pressure >= 25 mmHg at rest, PCWP = 3 Wood
units x m2 (if PCWP is not available, then mean LA pressure mmHg in the absence of left atrial obstruction).

- Females of child bearing potential who were sexually active must have been practicing
a suitable method of birth control so that in the opinion of the investigator, they
would not become pregnant during the study.

- Subjects who have symptomatic pulmonary arterial hypertension due to: primary
pulmonary hypertension; pulmonary arterial hypertension in the presence of a small or
hemodynamically insignificant congenital systemic to pulmonary shunt lesion that in
the opinion of the investigator is not the cause of pulmonary hypertension; collagen
vascular disease; congenital systemic-to-pulmonary shunts with a baseline resting room
air oxygen saturation >= 88% unrepaired or repaired at least 6 months prior to
screening; d-transposition of the great arteries repaired within the first 30 days of
life; or surgical repair of other congenital heart lesions at least 6 months prior to
screening and do not have clinically significant residual left-sided heart disease

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects, developmentally able to exercise, whose CPX exercise test functional
capacity is within the following parameters: Peak VO2 >= 10 mL/kg/min and mL/kg/min during screening CPX test;

- Written informed consent and assent where applicable before the subject is screened
for the study.

- Subjects who undergo a large shift in altitude (defined as approximately 5000 feet or
1524 meters) in order to participate in the study must reside at the "in study"
altitude for at least 90 days prior to baseline and during the study period.

Exclusion Criteria:

- Subjects with pulmonary hypertension secondary to sickle cell disease, any other
disease known to be associated with PAH, or any etiology other than those specified in
the inclusion criteria.

- Left-sided heart disease, including aortic or mitral valve disease (greater than
mild), restrictive or congestive cardiomyopathy; PCWP or LVEDP > 15 mmHg; LVEF determined by MUGA, angiography or echocardiography; LV shortening fraction determined by echocardiography, symptomatic coronary disease (demonstrable ischemia).

- Pericardial constriction; significant (2+ for regurgitation) valvular disease other
than tricuspid or pulmonary regurgitation; acutely decompensated heart failure within
previous 30 days from screening; atrial septostomy within previous 6 months of
screening;

- Hemodynamic instability or hypo- or hypertension at screening, i.e., SBP outside of
70?140 mmHg.

- A history of stroke, myocardial infarction or life threatening arrhythmia within 6
months of screening.

- Moderate to severe restrictive pulmonary disease (Total Lung Capacity or Forced Vital
Capacity

- Subjects with bronchopulmonary dysplasia (BPD) and other chronic lung diseases.

- History of pulmonary embolism.

- Subjects whose CPX test is limited by conditions other than pulmonary
hypertension-associated dyspnea or fatigue.

- Subjects who are known to be HIV positive

- Subjects with impairment of renal function (serum creatinine > 2.5x ULN ) or hepatic
function (ALT and/or AST > 3x ULN; and/or bilirubin >= 2 mg/dL). Hematological
abnormalities (e.g., severe anemia, Hgb

- Subjects who previously received bosentan and whose liver function tests taken at
screening are > 2x ULN.

- Subjects with any medical condition which in the opinion of the investigator may
interfere with treatment, evaluation of safety, and/or efficacy.

- Change in class of medication for CHF or PAH within the 10 days prior to qualifying
right heart catheterization.

- Subjects who are currently prescribed and/or taking nitrates or nitric oxide donors in
any form. Acute vasodilator testing with nitric oxide is permitted during hemodynamic
evaluation; taking chronic arginine supplementation including Heart Bar; therapy
involving parenteral inotropic medication or parenteral vasodilators within 3 months
of screening; current therapy with alpha-blockers, potent cytochrome P450 3A4
inhibitors (e.g., erythromycin, ketoconazole, itraconazole and protease inhibitors),
Ritonavir or Nicorandil; chronic treatment with off-label sildenafil, an endothelin
antagonist or prostacyclin/prostacyclin analogue within 30 days of randomization.

- Pregnant or lactating female.

- Any medical or psychological condition or social circumstances that would impair their
ability to participate reliably in the study or who were not likely to complete the
study for any reason; current or past illicit drug use or alcoholism excepting if
abstinence can be documented for >= 1 year.

- Participation in another clinical trial of an investigational drug or device
(including placebo) within 30 days of screening for entry into the present study.

- Subjects with known hereditary degenerative retinal disorders (such as retinitis
pigmentosa) or history of non-arteritic anterior ischemic optic neuropathy (NAION).

NCT00159913
Pfizer
Completed
A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.

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A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension.
This is a clinical research study designed to evaluate sildenafil for the treatment of Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with oral sildenafil given in three different doses, compared to placebo (inactive treatment). Efficacy will be measured by exercise and hemodynamics. Patients who complete this trial may be eligible to take part in an extension study, in which all patients will receive active treatment of sildenafil.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension, Children
  • Drug: Sildenafil citrate
    oral; 20mg, 40mg and 80 mg; 3 times a day(TID)
  • Drug: Sildenafil citrate
    oral; 10mg, 20mg and 40mg; 3 times a day(TID)
  • Drug: Placebo
    oral; 3 times a day(TID)
  • Drug: Sildenafil citrate
    oral; 10 mg; 3 times a day(TID)
  • Experimental: Sildenafil Low dose
    Intervention: Drug: Sildenafil citrate
  • Experimental: Sildenafil Medium dose
    Intervention: Drug: Sildenafil citrate
  • Experimental: Sildenafil High dose
    Intervention: Drug: Sildenafil citrate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
235
June 2008
June 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects aged from 1 to 17 years old and weighing >= 8 kg with a mean pulmonary artery pressure >= 25 mmHg at rest, PCWP <= 15 mmHg, and PVRI >= 3 Wood units x m2 (if PCWP is not available, then mean LA pressure <= 15 mmHg or LVEDP <= 15 mmHg in the absence of left atrial obstruction).
  • Females of child bearing potential who were sexually active must have been practicing a suitable method of birth control so that in the opinion of the investigator, they would not become pregnant during the study.
  • Subjects who have symptomatic pulmonary arterial hypertension due to: primary pulmonary hypertension; pulmonary arterial hypertension in the presence of a small or hemodynamically insignificant congenital systemic to pulmonary shunt lesion that in the opinion of the investigator is not the cause of pulmonary hypertension; collagen vascular disease; congenital systemic-to-pulmonary shunts with a baseline resting room air oxygen saturation >= 88% unrepaired or repaired at least 6 months prior to screening; d-transposition of the great arteries repaired within the first 30 days of life; or surgical repair of other congenital heart lesions at least 6 months prior to screening and do not have clinically significant residual left-sided heart disease consistent with the exclusion criteria.
  • Subjects, developmentally able to exercise, whose CPX exercise test functional capacity is within the following parameters: Peak VO2 >= 10 mL/kg/min and <= 28 mL/kg/min during screening CPX test;
  • Written informed consent and assent where applicable before the subject is screened for the study.
  • Subjects who undergo a large shift in altitude (defined as approximately 5000 feet or 1524 meters) in order to participate in the study must reside at the "in study" altitude for at least 90 days prior to baseline and during the study period.

Exclusion Criteria:

  • Subjects with pulmonary hypertension secondary to sickle cell disease, any other disease known to be associated with PAH, or any etiology other than those specified in the inclusion criteria.
  • Left-sided heart disease, including aortic or mitral valve disease (greater than mild), restrictive or congestive cardiomyopathy; PCWP or LVEDP > 15 mmHg; LVEF < 40% determined by MUGA, angiography or echocardiography; LV shortening fraction < 22% determined by echocardiography, symptomatic coronary disease (demonstrable ischemia).
  • Pericardial constriction; significant (2+ for regurgitation) valvular disease other than tricuspid or pulmonary regurgitation; acutely decompensated heart failure within previous 30 days from screening; atrial septostomy within previous 6 months of screening;
  • Hemodynamic instability or hypo- or hypertension at screening, i.e., SBP outside of 70?140 mmHg.
  • A history of stroke, myocardial infarction or life threatening arrhythmia within 6 months of screening.
  • Moderate to severe restrictive pulmonary disease (Total Lung Capacity or Forced Vital Capacity <= 60% of normal) or history of severe lung disease.
  • Subjects with bronchopulmonary dysplasia (BPD) and other chronic lung diseases.
  • History of pulmonary embolism.
  • Subjects whose CPX test is limited by conditions other than pulmonary hypertension-associated dyspnea or fatigue.
  • Subjects who are known to be HIV positive
  • Subjects with impairment of renal function (serum creatinine > 2.5x ULN ) or hepatic function (ALT and/or AST > 3x ULN; and/or bilirubin >= 2 mg/dL). Hematological abnormalities (e.g., severe anemia, Hgb < 10 g/dL, leukopenia, WBC < 2500/mL).
  • Subjects who previously received bosentan and whose liver function tests taken at screening are > 2x ULN.
  • Subjects with any medical condition which in the opinion of the investigator may interfere with treatment, evaluation of safety, and/or efficacy.
  • Change in class of medication for CHF or PAH within the 10 days prior to qualifying right heart catheterization.
  • Subjects who are currently prescribed and/or taking nitrates or nitric oxide donors in any form. Acute vasodilator testing with nitric oxide is permitted during hemodynamic evaluation; taking chronic arginine supplementation including Heart Bar; therapy involving parenteral inotropic medication or parenteral vasodilators within 3 months of screening; current therapy with alpha-blockers, potent cytochrome P450 3A4 inhibitors (e.g., erythromycin, ketoconazole, itraconazole and protease inhibitors), Ritonavir or Nicorandil; chronic treatment with off-label sildenafil, an endothelin antagonist or prostacyclin/prostacyclin analogue within 30 days of randomization.
  • Pregnant or lactating female.
  • Any medical or psychological condition or social circumstances that would impair their ability to participate reliably in the study or who were not likely to complete the study for any reason; current or past illicit drug use or alcoholism excepting if abstinence can be documented for >= 1 year.
  • Participation in another clinical trial of an investigational drug or device (including placebo) within 30 days of screening for entry into the present study.
  • Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic anterior ischemic optic neuropathy (NAION).
Sexes Eligible for Study: All
1 Year to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Canada,   Chile,   Colombia,   Guatemala,   Hungary,   India,   Italy,   Japan,   Malaysia,   Mexico,   Peru,   Poland,   Russian Federation,   Sweden,   Taiwan,   United States
Australia,   Costa Rica,   Panama,   Singapore
 
NCT00159913
A1481131
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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