NCT00125918

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2005

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 21, 2008

Status Verified

February 1, 2008

Enrollment Period

2 years

First QC Date

August 1, 2005

Last Update Submit

February 13, 2008

Conditions

Pulmonary Hypertension

Keywords

Hypertension, Pulmonary; Pulmonary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 6 minute walk distance change from baseline to Week 16

    16 weeks

Secondary Outcomes (2)

  • World Health Organization (WHO) functional class, Borg dyspnea, cardiopulmonary hemodynamics, quality of life - change from baseline to Week 16

    16 weeks

  • Time to first occurrence of clinical worsening

    Not defined

Study Arms (5)

1

PLACEBO COMPARATOR

Placebo

Drug: placebo

2

ACTIVE COMPARATOR

2.5 mg tadalafil

Drug: tadalafil

3

ACTIVE COMPARATOR

10 mg tadalafil

Drug: tadalafil

4

ACTIVE COMPARATOR

20 mg tadalafil

Drug: tadalafil

5

ACTIVE COMPARATOR

40 mg tadalafil

Drug: tadalafil

Interventions

tadalafilDRUG

tadalafil 2.5 mg and placebo tablets taken by mouth once a day for 16 weeks.

Also known as: LY450190, Cialis, IC351
2
placeboDRUG

placebo tablet taken by mouth once a day for 16 weeks

1

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • At least 12 years of age.
  • Body weight at least 40 kg (approximately 88 pounds).
  • Pulmonary hypertension (PAH) that is either idiopathic; related to collagen vascular disease; related to anorexigen use; associated with an atrial septal defect (resting SaO2 greater than or equal to 88%); with surgical repair, of at least 1 year duration, of a congenital systemic-to-pulmonary shunt.
  • If on bosentan, must be at the maximal dose of 125 mg twice daily for a minimum of 12 weeks prior to screening and have an AST/ALT less than 3 times normal.
  • History of PAH established by a resting mean pulmonary artery pressure greater than or equal to 25 mm Hg, pulmonary artery wedge pressure less than or equal to 15 mm Hg, and pulmonary vascular resistance greater than or equal to 3 Wood units via right heart catheterization
  • Have World Health Organization functional class I, II, III or IV status.
  • Have a qualifying 6-minute walk test distance at screening
  • Have no evidence of significant parenchymal lung disease

You may not qualify if:

  • Are nursing or pregnant.
  • History of left-sided heart disease.
  • History of atrial septostomy within 3 months before study entry
  • History of angina pectoris or other condition that was treated with long-or short-acting nitrates within 12 weeks before administration of study drug.
  • History of symptomatic coronary disease.
  • Have any therapy with a prostacyclin or analogue, L-arginine, phosphodiesterase (PDE) inhibitor, or investigational drug within 4 weeks before administration of study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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.

Tucson, Arizona, 85724, United States

Location

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.

Minneapolis, Minnesota, 55455, United States

Location

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.

Salt Lake City, Utah, 84143, United States

Location

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.

Lille, 59037, France

Location

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.

Vandœuvre-lès-Nancy, 54511, France

Location

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.

Bergamo, 24128, Italy

Location

Related Publications (2)

  • Ferguson-Sells L, Velez de Mendizabal N, Li B, Small D. Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model. Clin Pharmacokinet. 2022 Feb;61(2):249-262. doi: 10.1007/s40262-021-01052-8. Epub 2021 Aug 11.

    PMID: 34379314DERIVED

  • Galie N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, Shapiro S, White RJ, Chan M, Beardsworth A, Frumkin L, Barst RJ; Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009 Jun 9;119(22):2894-903. doi: 10.1161/CIRCULATIONAHA.108.839274. Epub 2009 May 26.

    PMID: 19470885DERIVED

Related Links

MeSH Terms

Conditions

Hypertension, PulmonaryHypertensionPulmonary Heart Disease

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesVascular DiseasesCardiovascular DiseasesHeart Diseases

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 1, 2005

First Posted

August 2, 2005

Study Start

August 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 21, 2008

Record last verified: 2008-02

Locations

US(3)FR(2)IT(1)