Pulmonary Arterial HypertensionNCT01066845
Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension, run by Eli Lilly and Company.
Trial summary
To investigate the long-term safety and effectiveness of Adcirca (tadalafil) in Pulmonary Arterial Hypertension (PAH) patients in the clinical practice -focused topics- 1. To evaluate the incidence of adverse events for the patients with long-term use 2. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- tadalafil
- How many people
- 1,809 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Japanese patients prescribed Adcirca from clinical practices
Who may be able to join
- Patients with PAH receiving Adcirca
- Exclusion Criteria:Patients who meet the criteria of contraindication
- patients with hypersensitivity to tadalafil
- patients who are using any form of organic nitrate
- patients with severe renal impairment
- patients with severe hepatic impairment
- patients taking strong inhibitors of CYP3A4
- patients taking strong inducers of CYP3A4
Who cannot join
None listed.
About this study
Official title: Safety and Effectiveness of Adcirca (Tadalafil) in Japanese Patients With Pulmonary Arterial Hypertension: Open-label, Non-interventional Observational Study in Japan
To investigate the long-term safety and effectiveness of Adcirca (tadalafil) in Pulmonary Arterial Hypertension (PAH) patients in the clinical practice -focused topics-
- To evaluate the incidence of adverse events for the patients with long-term use
- To evaluate the incidence of adverse events of decreased blood pressure, bleeding (including uterine hemorrhage), visual disturbance and sudden hearing loss.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- tadalafil
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tadalafilDrug
Also called LY450190, Adcirca, Cialis
prescribed in accordance with usual clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Patients prescribed Adcirca | all patients prescribed Adcirca during study period Receives: Drug: tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss.
Measured: 2 years
Secondary outcomes (5)
6 minute walk distance change from baseline
Measured: 2 years
World Health Organization (WHO) functional class change from baseline
Measured: 2 years
Survival time
Measured: 2 years
Pulmonary arterial pressure change from baseline
Measured: 2 years
Score change of Euro Quality of Life (EQ-5D) from baseline
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,809 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066845
- Sponsor's protocol ID
- 13693
- Other IDs
- H6D-JE-TD01
- Status last verified
- Oct 2015
- First submitted
- 3 Feb 2010
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Adcirca (Tadalafil) in Japanese Patients With Pulmonary Arterial Hypertension: Open-label, Non-interventional Observational Study in Japan
- ClinicalTrials.gov ID
- NCT01066845
- Acronym / sponsor ID
- 13693
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,809 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the long-term safety and effectiveness of Adcirca (tadalafil) in Pulmonary Arterial Hypertension (PAH) patients in the clinical practice -focused topics-
- To evaluate the incidence of adverse events for the patients with long-term use
- To evaluate the incidence of adverse events of decreased blood pressure, bleeding (including uterine hemorrhage), visual disturbance and sudden hearing loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients prescribed Adcirca | – | Drug: tadalafilall patients prescribed Adcirca during study period |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese patients prescribed Adcirca from clinical practices
Key inclusion criteria (8 listed)
- Patients with PAH receiving Adcirca
- Exclusion Criteria:Patients who meet the criteria of contraindication
- patients with hypersensitivity to tadalafil
- patients who are using any form of organic nitrate
- patients with severe renal impairment
Key exclusion criteria (0 listed)
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, Adcirca, Cialisprescribed in accordance with usual clinical practice | Drug | Patients prescribed Adcirca |
Primary outcome
The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss.
Time frame: 2 years
5 secondary outcomes
6 minute walk distance change from baseline
Time frame: 2 years
World Health Organization (WHO) functional class change from baseline
Time frame: 2 years
Survival time
Time frame: 2 years
Pulmonary arterial pressure change from baseline
Time frame: 2 years
Score change of Euro Quality of Life (EQ-5D) from baseline
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
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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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Eli Lilly and Company.
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 8 inclusion and 0 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 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss. (time frame: 2 years). 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 26 Oct 2015.