NCT00549302

Brief 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.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
357

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_3

Geographic Reach
10 countries

10 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

Study Start

First participant enrolled

December 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 18, 2013

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

6.2 years

First QC Date

October 23, 2007

Results QC Date

January 16, 2013

Last Update Submit

April 1, 2013

Conditions

Hypertension, Pulmonary

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events (AEs)

    A summary of serious and all other non-serious AEs, which include adverse events reported for laboratory tests and vital signs, is located in the Reported Adverse Event module.

    Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period)

Secondary Outcomes (3)

  • 6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52

    Baseline and Weeks 16, 28, 40 and 52

  • Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52

    Baseline and Weeks 16, 28, 40 and 52

  • Probability of No Pulmonary Arterial Hypertension (PAH) Deterioration at Weeks 16, 28, 40 and up to 52

    Baseline and Weeks 16, 28, 40 and 52

Study Arms (2)

20 mg tadalafil

ACTIVE COMPARATOR

20 milligram (mg) tadalafil taken once a day

Drug: tadalafil

40 mg tadalafil

ACTIVE COMPARATOR

40 mg tadalafil tablet taken once a day

Drug: tadalafil

Interventions

tadalafilDRUG

20 milligram (mg) tablet, taken by mouth once a day for 52 weeks for the phase 1 portion. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of Pulmonary Arterial Hypertension (PAH).

Also known as: LY450190, Cialis, IC351
20 mg tadalafil

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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, 97701, 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.

Brussels, Belgium

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.

Toronto, Ontario, Canada

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, 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.

Berlin, Germany

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.

Dublin, Ireland

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, Italy

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.

Tokyo, Japan

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.

Barcelona, Spain

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.

London, United Kingdom

Location

Related Publications (1)

  • Oudiz RJ, Brundage BH, Galie N, Ghofrani HA, Simonneau G, Botros FT, Chan M, Beardsworth A, Barst RJ; PHIRST Study Group. Tadalafil for the treatment of pulmonary arterial hypertension: a double-blind 52-week uncontrolled extension study. J Am Coll Cardiol. 2012 Aug 21;60(8):768-74. doi: 10.1016/j.jacc.2012.05.004. Epub 2012 Jul 18.

    PMID: 22818063DERIVED

Related Links

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

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

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

October 23, 2007

First Posted

October 25, 2007

Study Start

December 1, 2005

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 9, 2013

Results First Posted

February 18, 2013

Record last verified: 2013-04

Locations

CA(1)IT(1)BE(1)US(1)DE(1)ES(1)FR(1)JP(1)GB(1)IE(1)