Studies

Question 1

Freedom EV intervention

Answer 1

Orenitram TID on patients on background monotherapy

Question 2

Freedom EV primary endpoint

Answer 2

Adjudicated time to first clinical worsening event

Question 3

Freedom EV inclusion

Answer 3

WHO 1, stable monotherapy> 10d, no LH disease, PFTs <6mos, 6MW> 150m, TLC>60% FEV1>50%

Question 4

Freedom EV secondary endpoint

Answer 4

Change in 6MW at 24wks
NT-proBNP
Borg score
Combined Borg/6MW
WHO FC
Hemodynamics

Question 5

Griphon intervention

Answer 5

Selexipag vs placebo in patients on zero, one or two background PAH meds

Question 6

Griphon intervention primary endpoint

Answer 6

Composite of death or a complication related to PAH

Question 7

Griphon inclusion

Answer 7

WHO 1, PVR >5, stable background therapy

Question 8

Griphon secondary endpoint

Answer 8

Change in 6MW at 26wks
Absence of worsening WHO FC
Death any cause and PAH
NT-proBNP

Question 9

Griphon results

Answer 9

Risk of composite endpoint (death or complication related to PAH) lower with selexipag. Primary endpoint driven by reduction in hospitalizations. No mortality difference.

Question 10

Ambition intervention

Answer 10

Ambrisentan + tadalafil
Ambrisentan + placebo
Tadalafil + placebo

Question 11

Ambition intervention

Answer 11

Initial combination therapy vs initial monotherapy, previously untreated

Question 12

Ambition primary endpoint

Answer 12

Time to clinical failure (composite death, hospitalization for worsening PAH, disease progression, unsatisfactory clinical response

Question 13

Ambition outcome

Answer 13

Risk of clinical failure was significantly lower in those receiving initial combination therapy with ambrisentan/tadalafil vs monotherapy with either

Question 14

ADAPT

Answer 14

Real-world use and tolerability of orenitram, patient registry

Question 15

ADVANCE Outcomes

Answer 15

Time to clinical worsening study of patients on ralinepag in subjects with PAH on background therapy ERA and/or PDE5-i.

Question 16

BREEZE study

Answer 16

Phase 1b study of 45pts transitioning from stable doses of Tyvaso to DPI

Question 17

ADAPT inclusion

Answer 17

Prescribed orenitram and taking for fewer than 182 days, can answer surveys. Any background therapy

Question 18

EXPEDITE Objective

Answer 18

Evaluate dose of orenitram extended release tablets 16 weeks after induction with remodulin

Question 19

EXPEDITE primary endpoint

Answer 19

Percentage of pts achieving 4mg TID of orenitram or higher at week 16

Question 20

EXPEDITE inclusion

Answer 20

WHO II/III
6MW > 250m
WHO Group 1
On 0/1/2 background PAH therapies, stable doses
CI > 2.0

Question 21

EXPEDITE exclusion

Answer 21

EF < 50%
TLC<60 or FEV1<55
Renal insufficiency 
Sleep apnea
Life expectancy <12 mos
On PCY class drug within 28 days

Question 22

EVOLVE study objective

Answer 22

Prospective study of pts on remodulin with remunity pump

Question 23

What’s a DaQuery

Answer 23

Investigator studies of questions that can be answered by our Phase 4 info

Question 24

ADVANCE Capacity primary endpoint

Answer 24

Change in PVR on RHC

Question 25

ADVANCE Outcomes primary endpoint

Answer 25

Time to first adjudicated clincal worsening event

Question 26

PERFECT Objective

Answer 26

Inhaled treprotinil vs placebo in patients with PH-COPD. 6MW assessed at 12 weeks

Question 27

PERFECT design

Answer 27

Adaptive design crossover study where patients act as their own controls. On treatment drug and placebo each for 12 weeks with washout period between

Question 28

PERFECT primary endpoint

Answer 28

Change in 6MWD at 12 weeks

Question 29

TRITON Objective

Answer 29

Initial oral double therapy vs initial oral triple therapy looking at selexipag

Question 30

TRITON Inclusion

Answer 30

Naive to PAH therapy, PVR > 6 WU

Question 31

TRITON Intervention

Answer 31

Tadalafil + macitentan with wither selexipag vs placebo