Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension

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. Identifier: NCT01066845
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : October 26, 2015
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Drug: tadalafil

Study Type : Observational
Actual Enrollment : 1809 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety and Effectiveness of Adcirca (Tadalafil) in Japanese Patients With Pulmonary Arterial Hypertension: Open-label, Non-interventional Observational Study in Japan
Study Start Date : January 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Group/Cohort Intervention/treatment
Patients prescribed Adcirca
all patients prescribed Adcirca during study period
Drug: tadalafil
prescribed in accordance with usual clinical practice
Other Names:
  • LY450190
  • Adcirca
  • Cialis

Primary Outcome Measures :
  1. The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 6 minute walk distance change from baseline [ Time Frame: 2 years ]
  2. World Health Organization (WHO) functional class change from baseline [ Time Frame: 2 years ]
  3. Survival time [ Time Frame: 2 years ]
  4. Pulmonary arterial pressure change from baseline [ Time Frame: 2 years ]
  5. Score change of Euro Quality of Life (EQ-5D) from baseline [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japanese patients prescribed Adcirca from clinical practices

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

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 identifier (NCT number): NCT01066845

Sponsors and Collaborators
Eli Lilly and Company
Study Director: 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) Eli Lilly and Company

Responsible Party: Eli Lilly and Company Identifier: NCT01066845     History of Changes
Other Study ID Numbers: 13693
H6D-JE-TD01 ( Other Identifier: Eli Lilly and Company )
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents