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Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension

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Status

Completed

Conditions

Pulmonary Arterial Hypertension

Treatments

Drug: tadalafil

Study type

Observational

Funder types

Industry

Identifiers

NCT01066845
H6D-JE-TD01 (Other Identifier)
13693

Details and patient eligibility

About

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.

Enrollment

1,809 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • 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

Trial design

1,809 participants in 1 patient group

Patients prescribed Adcirca
Description:
all patients prescribed Adcirca during study period
Treatment:
Drug: tadalafil

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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