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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: September 26, 2011
Last verified: September 2011
History of Changes
  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:

Drug Information available for: Tadalafil
U.S. FDA Resources

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: December 2014
Estimated Primary Completion Date: December 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: September 26, 2011
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 May 23, 2013