Trial Outcomes & Findings for Treprostinil Combined With Tadalafil for Pulmonary Hypertension (NCT NCT01302444)

NCT ID: NCT01302444

Last Updated: 2013-07-26

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

16 weeks

Results posted on

2013-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	Tadalafil first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort	Placebo first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treprostinil Combined With Tadalafil for Pulmonary Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tadalafil n=1 Participants first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort	Placebo first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks	Total n=1 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age Categorical Between 18 and 65 years	1 participants n=5 Participants	—	1 participants n=5 Participants
Age Categorical >=65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Gender Female	1 participants n=5 Participants	—	1 participants n=5 Participants
Gender Male	0 participants n=5 Participants	—	0 participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: data not reported for one participant for anonymity

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 16 weeks

Population: data not reported for one participant for anonymity

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 16 weeks

Population: data not reported for one participant for anonymity

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 16 weeks

Population: data not reported for one participant for anonymity

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks of therapy

Population: data not reported for one participant for anonymity

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks of therapy

Population: data not reported for one participant for anonymity

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks of therapy

Population: data not reported for one participant for anonymity

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

Population: data not reported for one participant for anonymity

Outcome measures

Outcome data not reported

Adverse Events

Tadalafil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James R Klinger, MD

Rhode Island Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place