Hypertension, PulmonaryPhase 3NCT01824290
A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)
A Phase 3 study testing Tadalafil and ERA as specific PAH treatment in people with Hypertension, Pulmonary, run by Eli Lilly and Company at 43 sites in 14 countries.
Trial summary
The main purpose of this study is to evaluate the safety and efficacy of tadalafil in pediatric participants with pulmonary arterial hypertension. Participants will receive study treatment for 6 months in the double-blind period (Period 1), and then will be eligible to enroll into an open-label 2 year extension period… Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Tadalafil and ERA as specific PAH treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 43 sitesin 14 countries
- Study dates
- 5 Feb 2014to 10 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≥6 months to <18 years of age at screening
- Currently have a diagnosis of PAH that is either:
- idiopathic, including hereditary
- related to connective tissue disease
- related to anorexigen use
- associated with surgical repair of at least 6-month duration of congenital systemic to pulmonary shunt (eg, atrial septal defect, ventricular septal defect, patent ductus arteriosus)
Show all 12Show fewer
- Have a history of a diagnosis of PAH established by a resting mean pulmonary artery pressure (mPAP) ≥25 millimeter of mercury (mm Hg), pulmonary artery wedge pressure ≤15 mm Hg, and a pulmonary vascular resistance (PVR) ≥3 Wood units via right heart catheterization (RHC). In the event that a pulmonary artery wedge pressure cannot be obtained during RHC, participants with a left ventricular end diastolic pressure (LVEDP) <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 II or III at the time of screening
- All participants must be receiving an endothelin receptor antagonist (ERA) (such as bosentan or ambrisentan) and must be on a maintenance dose with no change in dose (other than weight-based adjustments) for at least 12 weeks prior to screening and have a screening aspartate transaminase (AST)/alanine transaminase (ALT) <3 times the upper limit of normal (ULN)
- If on conventional PAH medication, including but not restricted to, anticoagulants, diuretics, digoxin, and oxygen therapy, the participant must be on stable doses with no changes (other than weight-based adjustments) for at least 4 weeks before screening
- Female participants of childbearing potential must test negative for pregnancy during screening. Furthermore, female participants must agree to abstain from sexual activity or to use two different reliable methods of birth control as determined by the Investigator during the study. Examples of reliable birth control methods include true abstinence as a lifestyle choice (periodic sexual abstinence method is not acceptable); the use of oral contraceptives; a reliable barrier method of birth control (diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices)
- Written informed consent from parents (and written assent from appropriately aged participants) will be obtained prior to any study procedure being performed
Who cannot join
- 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
- History of left-sided heart disease, including any of the following:
- clinically significant [pulmonary artery occlusion pressure (PAOP) 15-18 mm Hg] aortic or mitral valve disease (ie, 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
Show all 30Show fewer
- left ventricular shortening fraction <22% by echocardiography
- life-threatening cardiac arrhythmias
- symptomatic coronary artery disease within 5 years of study entry
- Unrepaired congenital heart disease
- Have a history of angina pectoris or other condition that was treated with long- or short-acting nitrates within 12 weeks before administration of study drug
- Have severe hepatic impairment, Child-Pugh Grade C
- Have severe renal insufficiency, defined as receiving renal dialysis or having a measured or estimated creatinine clearance (CC) <30 millimeter per minute (mL/min) (Schwartz Formula)
- Diagnosed with a retinal disorder (eg, hereditary retinal disorders, retinopathy of the preterm participant and other retinal disorders)
- Have severe hypotension or uncontrolled hypertension as determined by the Investigator
- Have significant parenchymal lung disease
- Have bronchopulmonary dysplasia
- Concurrent phosphodiesterase type 5 (PDE5) inhibitor therapy (sildenafil or vardenafil) or has received PDE5 inhibitor therapy within 12 weeks prior to the first study drug dosing
- Concurrent therapy with prostacyclin or its analogues within 12 weeks of screening
- Commenced or discontinued a chronic conventional PAH medication including but not restricted to: diuretics, anti-coagulants, digoxin, and oxygen therapy within 4 weeks of screening
- Currently receiving treatment with doxazosin, nitrates, or cancer therapy
- Current treatment with potent Cytochrome P450 3A4 (CYP3A4) inhibitors, such as antiretroviral therapy (protease inhibitor), systemic ketoconazole, or systemic itraconazole, or chronic use of potent CYP3A4 inducers, such as rifampicin
- Are nursing or pregnant
- Have previously completed or withdrawn from this study (LVHV), or any other study investigating tadalafil
- Have received tadalafil therapy within 12 weeks prior to the first study drug dosing or are hypersensitive to tadalafil
- Have allergy to the excipients, notably lactose
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study by the Sponsor
- Unable to take orally administered tablets (without chewing, crushing or breaking) or suspension
- Are Investigator site personnel directly affiliated with this study or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted
- Diagnosis of Down syndrome
Trial locations and contacts
43 sites in 14 countries.
43 sites in 14 countries
Japan8 sites
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, 078-8510
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, 183-8561
Okinawa Prefectural Nanbu Medical Center & Children's Med Ct
Haebaru-cho, Shimajiri-gun, Okinawa, 901-1193
Toho University Omori Medical Center
Ohta-Ku, Tokyo, 143-8541
National Center For Child Health And Development
Setagaya-ku, Tokyo, 157-8535
Gunma Children's Medical Center
Shibukawa, Gunma, 377-8577
Shizuoka Prefectural Children's Hospital
Shizuoka, 420-8660
Mie University Hospital
Tsu, Mie-ken, 514-8507
United States7 sites
Children's Heathcare of Atlanta, Inc. at Egleston
Atlanta, Georgia, 30322
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hosp
Columbus, Ohio, 43205-2664
Childrens Hospital of Michigan
Detroit, Michigan, 48201
Texas Childrens Hospital
Houston, Texas, 77030
Vanderbilt Univeristy School of Medicine
Nashville, Tennessee, 37212-2372
Primary Childrens Medical Center
Salt Lake City, Utah, 84132
Brazil4 sites
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Pronto Socorro Cardiologico de Pernambuco-PROCAPE
Recife, Pernambuco, 50100-060
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-180
UNIFESP - Escola Paulista de Medicina
São Paulo, São Paulo, 04037-002
France4 sites
CHU Hopital d'enfants de la Timone
Marseille, 13385
GH Necker - Enfants Malades
Paris, 75743
Hopital Haut Leveque - Group hospitalier Sud
Pessac, 33604
Chu de Toulouse - Hopital des Enfants
Toulouse, 31026
Poland4 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Uniwersytecki Szpital Dzieciecy w Krakowie-Prokocimiu
Krakow, 30-633
Instytut Pomnik-Centrum Zdrowia Dziecka
Warsaw, Woj Mazowieckie, 04-730
Wojewódzki Szpital Specjalistyczny we Wrocławiu
Wroclaw, 51-124
Italy3 sites
Istituto Giannina Gaslini Ospedale Pediatrico I.R.C.C.S.
Genova, GE, 16147
Ospedale V. Monaldi
Naples, 80131
Ospedale Bambino Gesu
Roma, 00165
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Germany2 sites
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89075
Israel2 sites
Schneider Medical Center
Petah Tikva, 4920235
Sheba Medical Center
Tel HaShomer, Ramat Gan, 5265601
Turkey (Türkiye)2 sites
Hacettepe University Faculty of Medicine
Ankara, 06100
Gazi University Medical Faculty
Besevler/Ankara, 06500
Belgium1 site
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000
Mexico1 site
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, Mexico City, 14080
Netherlands1 site
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
About this study
Official title: A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial Hypertension
The main purpose of this study is to evaluate the safety and efficacy of tadalafil in pediatric participants with pulmonary arterial hypertension. Participants will receive study treatment for 6 months in the double-blind period (Period 1), and then will be eligible to enroll into an open-label 2 year extension period (Period 2) during which participants will receive tadalafil.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Tadalafil, Placebo, ERA as specific PAH treatment
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TadalafilDrug
Also called LY450190, Cialis, Adcirca, IC351
Administered orally by tablet form for heavy and middle weight participants. Administered orally by suspension for light weight participants.
PlaceboDrug
Administered orally by tablet for heavy and middle weight participants. Administered orally by suspension for light weight participants.
ERA as specific PAH treatmentDrug
All participants were taking endothelin receptor antagonist (ERA) (such as bosentan, ambrisentan and macitentan).
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil | Experimental | Period 1: 20 mg or 40 mg administered orally by tablets once a day.
Period 2: 20 mg for middle weight and 40 mg for heavy weight administered orally by tablets once a day.
Final tadalafil doses for Period 1 (6-month double-blind) were assigned after the weight cohort completion from H6D-MC-LVIG (NCT01484431).Tadalafil doses would range from 5 milligram (mg) to 40 mg depending on body weight cohorts. Heavy weight cohort ≥40 kilogram (kg), Middle weight cohort ≥25 kg to <40 kg: administered orally by tablets once a day. Light weight cohort <25 kg: administered orally by suspension once a day.
Participants receiving tadalafil in Period 1 continued to receive tadalafil during Period 2 (2-year open-label extension). Receives: Drug: Tadalafil; Drug: ERA as specific PAH treatment |
| Placebo | Placebo comparator | Period 1: Participants received placebo orally by tablets once a day.
Period 2: 20 mg for middle weight and 40 mg for heavy weight administered orally by tablets once a day.
Final placebo dose for Period 1 (6-month double-blind) was be assigned after the weight cohort completion from H6D-MC-LVIG (NCT01484431) to maintain blinding depending on body weight cohort.
Participants receiving placebo in Period 1 Period 2 (2-year open-label extension) would receive tadalafil in Period 2 at the corresponding tadalafil dose in that participant's weight group. Receives: Drug: Placebo; Drug: ERA as specific PAH treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period 1: Change From Baseline to Week 24 in a 6 Minute Walk (MW) Distance in Meters
6MWD in meters assessed in a subset of participants who are ≥6 to <18 years of age who are developmentally capable of performing a 6MW test. Change from baseline was derived using mixed model repeated measures (MMRM) with terms for treatment group, visit, baseline 6MWD, and treatment-by-visit interaction.
Measured: Baseline, Week 24
Secondary outcomes (5)
Period 1: Time to Adjudicated Clinical Worsening (CW)
Clinical worsening was defined as any of the following: death,lung or heart transplantation,atrial septostomy or Potts' shunt,hospitalization for Pulmonary Arterial Hypertension(PAH) progression,new onset syncope,initiation of new PAH therapy(including increase in the dose of existing PAH specific concomitant therapy,such as endothelin receptor agonist or beraprost medication), or increase of 1 or more in World Health Organization(WHO) Functional Class(except for participants already in Class IV;only for participants unable to perform the 6 minute walk(6MW) test;worsening of WHO functional class by 1 or more for participants who can perform a 6 minute walk(6MW) test and who have a decrease of ≥ 20% in the 6 minute walk distance(for those participants who are ≥6 years of age). Criteria for CW(from Period 1) were adjudicated by an independent,blinded study-specific Clinical Endpoint Committee(CEC).This adjudication was used for data analysis, and was not used to guide subject treatment.
Measured: Baseline through Week 24
Period 1: Percentage of Participants Who Experience CW
Clinical worsening was defined as any of the following: death,lung or heart transplantation,atrial septostomy or Potts' shunt,hospitalization for Pulmonary Arterial Hypertension(PAH) progression,new onset syncope, initiation of new PAH therapy(including increase in the dose of existing PAH specific concomitant therapy,such as endothelin receptor agonist or beraprost medication),or increase of 1 or more in World Health Organization(WHO) Functional Class(except for participants already in Class IV; only for participants unable to perform the 6 minute walk(6MW) test;worsening of WHO functional class by 1 or more for participants who can perform a 6 minute walk(6MW) test and who have a decrease of ≥ 20% in the 6 minute walk distance(for those participants who are ≥6 years of age).Criteria for CW(from Period 1) were adjudicated by an independent,blinded study-specific Clinical Endpoint Committee(CEC).This adjudication was used for data analysis, and was not used to guide subject treatment.
Measured: Baseline through Week 24
Period 1: Pharmacokinetics (PK): Apparent Clearance (CL/F) of Tadalafil at Steady-state
Period 1: Pharmacokinetics (PK): Apparent Clearance (CL/F) of Tadalafil at steady-state
Measured: Week 2, Week 4, Week 16 and Week 24
Period 2: Percentage of Participants Who Experience CW
Clinical worsening was defined as any of the following: death, lung or heart transplantation, atrial septostomy or Potts' shunt, hospitalization for Pulmonary Arterial Hypertension (PAH) progression, new onset syncope, initiation of new PAH therapy (including increase in the dose of existing PAH specific concomitant therapy, such as endothelin receptor agonist or beraprost medication), or increase of 1 or more in World Health Organization(WHO) Functional Class (except for participants already in Class IV; only for participants unable to perform the 6 minute walk (6MW) test; worsening of WHO functional class by 1 or more for participants who can perform a 6 minute walk (6MW) test and who have a decrease of ≥ 20% in the 6 minute walk distance (for those participants who are ≥6 years of age).
Measured: Period 2 Baseline through Study Completion (Up to 24 Months)
Period 2: Time to First Occurrence of CW
Clinical worsening was defined as any of the following: death, lung or heart transplantation, atrial septostomy or Potts' shunt, hospitalization for Pulmonary Arterial Hypertension (PAH) progression, new onset syncope, initiation of new PAH therapy (including increase in the dose of existing PAH specific concomitant therapy, such as endothelin receptor agonist or beraprost medication), or increase of 1 or more in World Health Organization(WHO) Functional Class (except for participants already in Class IV; only for participants unable to perform the 6 minute walk (6MW) test; worsening of WHO functional class by 1 or more for participants who can perform a 6 minute walk (6MW) test and who have a decrease of ≥ 20% in the 6 minute walk distance (for those participants who are ≥6 years of age).
Measured: Period 2 Baseline through Study Completion (Up to 24 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study start5 Feb 2014
- Primary completion18 Mar 2019
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824290
- Sponsor's protocol ID
- 10609
- Other IDs
- H6D-MC-LVHV, 2012-002354-23
- Status last verified
- Nov 2021
- First submitted
- 1 Apr 2013
- Last updated
- 5 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01824290
- Acronym / sponsor ID
- 10609
- Conditions
- Hypertension, Pulmonary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2014 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety and efficacy of tadalafil in pediatric participants with pulmonary arterial hypertension. Participants will receive study treatment for 6 months in the double-blind period (Period 1), and then will be eligible to enroll into an open-label 2 year extension period (Period 2) during which participants will receive tadalafil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tadalafil | Experimental | Drug: Tadalafil, Drug: ERA as specific PAH treatmentPeriod 1: 20 mg or 40 mg administered orally by tablets once a day. Period 2: 20 mg for middle weight and 40 mg for heavy weight administered orally by tablets once a day. Final tadalafil doses for Period 1 (6-month double-blind) were assigned after the weight cohort completion from H6D-MC-LVIG (NCT01484431).Tadalafil doses would range from 5 milligram (mg) to 40 mg depending on body weight cohorts. Heavy weight cohort ≥40 kilogram (kg), Middle weight cohort ≥25 kg to <40 kg: administered orally by tablets once a day. Light weight cohort <25 kg: administered orally by suspension once a day. Participants receiving tadalafil in Period 1 continued to receive tadalafil during Period 2 (2-year open-label extension). |
| Placebo | Placebo comparator | Drug: Placebo, Drug: ERA as specific PAH treatmentPeriod 1: Participants received placebo orally by tablets once a day. Period 2: 20 mg for middle weight and 40 mg for heavy weight administered orally by tablets once a day. Final placebo dose for Period 1 (6-month double-blind) was be assigned after the weight cohort completion from H6D-MC-LVIG (NCT01484431) to maintain blinding depending on body weight cohort. Participants receiving placebo in Period 1 Period 2 (2-year open-label extension) would receive tadalafil in Period 2 at the corresponding tadalafil dose in that participant's weight group. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- ≥6 months to <18 years of age at screening
- Currently have a diagnosis of PAH that is either:
- Have a history of a diagnosis of PAH established by a resting mean pulmonary artery pressure (mPAP) ≥25 millimeter of mercury (mm Hg), pulmonary artery wedge pressure ≤15 mm Hg, and a pulmonary vascular resistance (PVR) ≥3 Wood units via right heart catheterization (RHC). In the event that a pulmonary artery wedge pressure cannot be obtained during RHC, participants with a left ventricular end diastolic pressure (LVEDP) <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 II or III at the time of screening
- All participants must be receiving an endothelin receptor antagonist (ERA) (such as bosentan or ambrisentan) and must be on a maintenance dose with no change in dose (other than weight-based adjustments) for at least 12 weeks prior to screening and have a screening aspartate transaminase (AST)/alanine transaminase (ALT) <3 times the upper limit of normal (ULN)
Key exclusion criteria (30 listed)
- 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
- History of left-sided heart disease, including any of the following:
- Unrepaired congenital heart disease
- Have a history of angina pectoris or other condition that was treated with long- or short-acting nitrates within 12 weeks before administration of study drug
- Have severe hepatic impairment, Child-Pugh Grade C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TadalafilAlso: LY450190, Cialis, Adcirca, IC351Administered orally by tablet form for heavy and middle weight participants. Administered orally by suspension for light weight participants. | Drug | Tadalafil |
| PlaceboAdministered orally by tablet for heavy and middle weight participants. Administered orally by suspension for light weight participants. | Drug | Placebo |
| ERA as specific PAH treatmentAll participants were taking endothelin receptor antagonist (ERA) (such as bosentan, ambrisentan and macitentan). | Drug | Placebo, Tadalafil |
Primary outcome
Period 1: Change From Baseline to Week 24 in a 6 Minute Walk (MW) Distance in Meters
Time frame: Baseline, Week 24
6MWD in meters assessed in a subset of participants who are ≥6 to <18 years of age who are developmentally capable of performing a 6MW test. Change from baseline was derived using mixed model repeated measures (MMRM) with terms for treatment group, visit, baseline 6MWD, and treatment-by-visit interaction.
5 secondary outcomes
Period 1: Time to Adjudicated Clinical Worsening (CW)
Time frame: Baseline through Week 24
Period 1: Percentage of Participants Who Experience CW
Time frame: Baseline through Week 24
Period 1: Pharmacokinetics (PK): Apparent Clearance (CL/F) of Tadalafil at Steady-state
Time frame: Week 2, Week 4, Week 16 and Week 24
Period 2: Percentage of Participants Who Experience CW
Time frame: Period 2 Baseline through Study Completion (Up to 24 Months)
Period 2: Time to First Occurrence of CW
Time frame: Period 2 Baseline through Study Completion (Up to 24 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
43 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tadalafil and ERA as specific PAH treatment in people with Hypertension, Pulmonary, run by Eli Lilly and Company at 43 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Japan, United States, Brazil, France, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Period 1: Change From Baseline to Week 24 in a 6 Minute Walk (MW) Distance in Meters (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.