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OpenTrials
Completed

NCT Number: NCT01066845

Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tadalafil

Drug

prescribed in accordance with usual clinical practice

Other names: LY450190, Adcirca, Cialis

Primary outcomes

  1. The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss.

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Safety and Effectiveness of Adcirca (Tadalafil) in Japanese Patients With Pulmonary Arterial Hypertension: Open-label, Non-interventional Observational Study in Japan

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 10, 2010
Registry last updated
Oct 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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