Post Marketing Observational Study in Patients With Pulmo... | NCT01066845

Studies
Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension

NCT01066845

Sponsor

Eli Lilly and Company

Status

Completed

Last Update Posted

Oct 26, 2015Estimated

Enrollment

1,809Actual

Phase

Not provided

Conditions

Pulmonary Arterial Hypertension

Interventions

tadalafil

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
H6D-JE-TD01	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Feb 3, 2010

First Submission Date that Met QC Criteria

Feb 9, 2010

First Posted Date

Feb 10, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2015

Last Update Posted Date

Oct 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate the long-term safety and effectiveness of Adcirca (tadalafil) in Pulmonary Arterial Hypertension (PAH) patients in the clinical practice -focused topics-

To evaluate the incidence of adverse events for the patients with long-term use
To evaluate the incidence of adverse events of decreased blood pressure, bleeding (including uterine hemorrhage), visual disturbance and sudden hearing loss.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,809Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients prescribed Adcirca		all patients prescribed Adcirca during study period	Drug: tadalafil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tadalafil	Drug	prescribed in accordance with usual clinical practice	Patients prescribed Adcirca

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss.		2 years

Secondary Outcomes

Measure	Description	Time Frame
6 minute walk distance change from baseline		2 years
World Health Organization (WHO) functional class change from baseline		2 years
Survival time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Japanese patients prescribed Adcirca from clinical practices

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000081029	Pulmonary Arterial Hypertension

Ancestor Terms

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068581	Tadalafil

Ancestor Terms

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided