Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01066845
First received: February 3, 2010
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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 Intervention
Pulmonary Arterial Hypertension
Drug: tadalafil

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Secondary Outcome Measures:
  • 6 minute walk distance change from baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • World Health Organization (WHO) functional class change from baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Survival time [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Pulmonary arterial pressure change from baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Score change of Euro Quality of Life (EQ-5D) from baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: January 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed Adcirca
all patients prescribed Adcirca during study period
Drug: tadalafil
prescribed in accordance with usual clinical practice
Other Names:
  • LY450190
  • Adcirca
  • Cialis

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Japanese patients prescribed Adcirca from clinical practices

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066845

Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01066845     History of Changes
Other Study ID Numbers: 13693, H6D-JE-TD01
Study First Received: February 3, 2010
Last Updated: August 12, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Tadalafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014