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

Lilly

Status and phase: Completed; Phase 3

Conditions: Hypertension, Pulmonary

Treatments: Drug: tadalafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00549302

10263

H6D-MC-LVGX (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 357 patients

Sex: All

Ages: 12+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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357 participants in 2 patient groups

20 mg tadalafil

Active Comparator group

Description:

20 milligram (mg) tadalafil taken once a day

Treatment:

Drug: tadalafil

Drug: tadalafil

40 mg tadalafil

Active Comparator group

Description:

40 mg tadalafil tablet taken once a day

Treatment:

Drug: tadalafil

Drug: tadalafil