Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension

NCT ID: NCT01066845

Last Updated: 2015-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1809 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-08-31

Brief Summary

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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. To evaluate the incidence of adverse events of decreased blood pressure, bleeding (including uterine hemorrhage), visual disturbance and sudden hearing loss.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients prescribed Adcirca

all patients prescribed Adcirca during study period

tadalafil

Intervention Type DRUG

prescribed in accordance with usual clinical practice

Interventions

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tadalafil

prescribed in accordance with usual clinical practice

Intervention Type DRUG

Other Intervention Names

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LY450190 Adcirca Cialis

Eligibility Criteria

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Inclusion Criteria

* Patients with PAH receiving Adcirca

Exclusion Criteria

* 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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Other Identifiers

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13693

Identifier Type: -

Identifier Source: org_study_id

H6D-JE-TD01

Identifier Type: OTHER

Identifier Source: secondary_id

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