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COMPLETEDPHASE3

Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs

An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients With Pulmonary Arterial Hypertension

NCT00549302•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

Study to determine the long term safety of tadalafil in patients with increased blood pressure in the blood vessel that carries blood from the right heart to the lungs and to see if it will keep the disease from getting worse.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must have participated and discontinued in the previous PAH placebo controlled study due to clinical worsening on placebo or tadalafil 2.5 mg, 10mg, or 20 mg
•Must have completed Week 16 of the previous PAH study and had either no clinical worsening or became clinically worse at the Week 16 visit on placebo or tadalafil 2.5 mg, 10mg, or 20 mg
•Females who have a negative urine pregnancy test and are willing to use 2 types of birth control
•Be 12 years or older (country specific regulations apply) with parental approval

Exclusion Criteria

•Participated in the placebo controlled study and had clinical worsening on 40 mg tadalafil
•Have left-sided heart disease
•Have a musculoskeletal disorder that limits being able to get around
•Nitrate use
•Certain current systemic treatments

Locations (10)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bend, Oregon, United States

Brussels, Belgium

Toronto, Ontario, Canada

Lille, France

Berlin, Germany

Dublin, Ireland

Bergamo, Italy

Tokyo, Japan

Barcelona, Spain

London, United Kingdom

Key Dates

Start Date

December 1, 2005

Primary Completion Date

February 1, 2012

Completion Date

February 1, 2012

Last Updated

April 9, 2013

Enrollment

357

ACTUAL participants

Conditions

Hypertension, Pulmonary

Interventions

tadalafil

DRUG

tadalafil

DRUG

A Deep-Learning-Enabled Electrocardiogram for Detecting Pulmonary Hypertension

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Artificial Intelligence (AI)Artificial Intelligence (AI) in Diagnosis+1 more

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RECRUITINGNA

Functional Pulmonary Capillary Surface Area in BPA for CTEPH

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Hypertension, PulmonaryPulmonary Thromboembolisms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs

Inclusion Criteria

Exclusion Criteria

A Deep-Learning-Enabled Electrocardiogram for Detecting Pulmonary Hypertension

Functional Pulmonary Capillary Surface Area in BPA for CTEPH

Real-World Study of PADN for the Treatment of PAH

Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

A Study of the Efficacy and Safety of Frespaciguat (MK-5475) in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)