A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01484431 |
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Recruitment Status :
Active, not recruiting
First Posted : December 2, 2011
Last Update Posted : August 21, 2017
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
- Study Details
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Brief Summary:
The purpose of this study to see how much study drug is in the blood after dosing children with pulmonary arterial hypertension (PAH) and to establish the correct dose for further clinical research.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Arterial Hypertension | Drug: Tadalafil- Tablet | Phase 1 Phase 2 |
During Period I, tadalafil will be administered orally, once daily, at a low dose for approximately 5 weeks followed by a high dose for approximately 5 weeks. Dose levels are calculated based on body weight cohorts. Heavy weight cohort >=40 kg, middle weight cohort >=25 kg to <40 kg. Light weight cohort<25 kg. Participants who complete Period 1 may continue taking tadalafil in Period 2 for at least 2 years. Starting dose will not exceed the maximum weight range dose established in Period 1 and may be adjusted based on available safety and efficacy information.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 24 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial Hypertension |
| Study Start Date : | July 2012 |
| Actual Primary Completion Date : | April 2017 |
| Estimated Study Completion Date : | May 2019 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Pulmonary arterial hypertension
Drug Information available for:
Tadalafil
| Arm | Intervention/treatment |
|---|---|
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Experimental: tadalafil
The dose of tadalafil will be escalated from low to high for each participant based on body weight for 5 weeks at low dose and 5 weeks at high dose.
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Drug: Tadalafil- Tablet
Tadalafil tablets: 2.5 mg and 5 mg, 10 mg, 20 mg and 40 mg (two 20 mg) administered orally, once daily in the heavy weight cohort >=40 kg and middle weight cohort >=25 kg to <40 kg Drug: Tadalafil - Oral suspension Tadalafil Oral suspension: 1 mg, 5 mg administered orally, once daily in the light weight cohort <25 kg |
Primary Outcome Measures :
- Pharmacokinetics: Area under the concentration time curve for tadalafil [ Time Frame: Period 1: pre dose up to 24 hours post dose ]
- Pharmacokinetics: Maximum plasma concentration for tadalafil [ Time Frame: Period 1: pre dose up to 24 hours post dose ]
Secondary Outcome Measures :
- Change from baseline to endpoint in World Health Organization (WHO) functional class [ Time Frame: Period 1: baseline, 10 weeks ]
- Change from baseline to endpoint in 6 minute walk distance for participants greater than or equal to 7 years of age [ Time Frame: Period 1: baseline, 10 weeks ]
- Percent increase from baseline to endpoint in N Terminal-Pro Brain Natriuretic Peptide (NT-Pro-BNP) [ Time Frame: Period 1: baseline and 10 weeks ]
- Percentage of participants with clinical worsening [ Time Frame: Period 2: baseline up to 2 years ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 6 Months to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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Currently have a diagnosis of PAH that is either:
- idiopathic (including hereditary), related to collagen vascular disease, related to anorexigen use, associated with surgical repair, of at least 6 month duration, of a congenital systemic to pulmonary shunt (for example, atrial septal defect, ventricular septal defect, patent ductus arteriosus).
- Have a history of the diagnosis of PAH established by a resting mean pulmonary artery pressure ≥25 mm Hg, pulmonary artery wedge pressure ≤15 mm Hg, and a pulmonary vascular resistance (PVR) ≥3 Wood units via right heart catheterization. In the event that a pulmonary artery wedge pressure is unable to be obtained during right heart catheterization, participants with a left ventricular end diastolic pressure <15 mm Hg, with normal left heart function, and absence of mitral stenosis on echocardiography can be eligible for enrollment
- Have a World Health Organization (WHO) functional class value of I, II or III at the time of enrollment
Exclusion Criteria:
- Have pulmonary hypertension related to conditions other than specified above, including but not limited to chronic thromboembolic disease, portal pulmonary hypertension, left-sided heart disease or lung disease and hypoxia
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History of left-sided heart disease, including any of the following:
- clinically significant (pulmonary artery occlusion pressure [PAOP] 15 to 18 mm Hg) aortic or mitral valve disease (that is, aortic stenosis, aortic insufficiency, mitral stenosis, moderate or greater mitral regurgitation)
- pericardial constriction
- restrictive or congestive cardiomyopathy
- left ventricular ejection fraction <40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography
- left ventricular shortening fraction <22% by echocardiography
- life-threatening cardiac arrhythmias
- symptomatic coronary artery disease within 5 years of study entry as determined by the physician
- History of atrial septostomy or Potts Shunt within 3 months before administration of study drug
- Unrepaired congenital heart disease
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484431
Locations
| United States, Colorado | |
| Children's Hospital of Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Georgia | |
| Children's Heathcare of Atlanta, Inc. at Egleston | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Indiana | |
| Riley Hosptial for Children | |
| Indianapolis, Indiana, United States, 46202-5225 | |
| United States, Ohio | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205-2664 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Canada, Quebec | |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Canada | |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | |
| Toronto, Canada, M5G 1X8 | |
| France | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Marseille, France, 13385 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Paris, France, 75743 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Toulouse, France, 31026 | |
| Poland | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Gdansk, Poland, 80-952 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Warszawa, Poland, 00-576 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Warszawa, Poland, 04-730 | |
| Spain | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Barcelona, Spain, 08035 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Madrid, Spain, 28041 | |
| United Kingdom | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Bloomsbury, London, United Kingdom, WC1N 3JH | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Additional Information:
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01484431 History of Changes |
| Other Study ID Numbers: |
12917 H6D-MC-LVIG ( Other Identifier: Eli Lilly and Company ) |
| First Posted: | December 2, 2011 Key Record Dates |
| Last Update Posted: | August 21, 2017 |
| Last Verified: | August 2017 |
Additional relevant MeSH terms:
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Hypertension Familial Primary Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases |
Tadalafil Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |