Completed Pulmonary Hypertension Trials
67896062CTP3001 - MACiTEPH
A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension
- Enrollment Status: Completed
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: Macitentan or Placebo
- Sponsor: Actelion
- PI: Leslie A. Spikes, MD
67896062PAH4005 - CARE-PAH
An International Non-Drug, Interventional, Real-World Cohort of PAH Patients Newly Initiating PAH Therapy with Guideline Directed Assessments of Disease Severity.
- Enrollment Status: Completed
- Study Type: Observational
- Sponsor: Actelion
- PI: Lewis G. Satterwhite, MD
A011-09 - PULSAR
A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
- Enrollment Status: Completed
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: Sotatercept or Placebo
- Sponsor: Acceleron Pharma
- PI: Leslie A. Spikes, MD
A011-11 - STELLAR
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
- Enrollment Status: Completed
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: Sotatercept or Placebo
- Sponsor: Acceleron Pharma
- PI: Leslie A. Spikes, MD
AC-055-503 - OPUS Registry
US-based, observational, drug registry of Opsumit® (macitentan) new users in clinical practice
- Enrollment Status: Completed
- Study Type: Observational
- PI: Leslie A. Spikes, MD
AC-0550510 - OrPHeUS
Multicenter, retrospective chart review of first-time Opsumit® (macitentan) users in the United States
- Enrollment Status: Completed
- Study Type: Observational
- PI: Leslie A. Spikes, MD
BIA-51058-203-UpRight
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase IIb Study with Open-Label Extension to Demonstrate the Efficacy and Safety of Zamicastat (BIA 5-1058) as Adjunctive Therapy in Pulmonary Arterial Hypertension (PAH) Patients with Right Ventricular (RV) Systolic Dysfunction.
- Enrollment Status: Terminated
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: BIA 5-1058 or Placebo
- Sponsor: BIAL
- PI: Leslie A. Spikes, MD
CXA-10-301 - PRIMEx
Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects with Pulmonary Arterial Hypertension (PAH)
- Enrollment Status: Terminated
- Study Type: Interventional
- PI: Leslie A. Spikes, MD
CXA-10-2302 - PRIMEx OLE
A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects with Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301
- Enrollment Status: Terminated
- Study Type: Interventional
- PI: Leslie A. Spikes, MD
GB002-2101 - TORREY
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH).
- Enrollment Status: Completed
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: GB002 or Placebo
- Sponsor: Gossamer Bio
- PI: Leslie A. Spikes, MD
INS1009-211
A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease.
- Enrollment Status: Closed
- Study Type: Interventional
- Intervention/Treatment: Treprostinil Palmitil Inhalation Powder or Placebo
- Sponsor: Insmed
- PI: Leslie A. Spikes, MD
RVT-1201-2002 - ELEVATE 2
A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension
- Enrollment Status: Completed
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: Rodatristal Ethyl or Placebo
- Sponsor: Altavant Sciences
- PI: Leslie A. Spikes, MD
LTI-301 - INSPIRE
A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients
- Enrollment Status: Completed
- Study Type: Interventional
- PI: Leslie A. Spikes, MD
PB1046-PT-CL-0004-VIP
A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension.
- Enrollment Status: Terminated
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: Pemziviptadil (PB1046) or Placebo
- Sponsor: PhaseBio
- PI: Leslie A. Spikes, MD
PB1046-PT-CL-0004-VIP-EXTEND
A Long-Term, Open Label Extension Study of PB1046 Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Stuidy PB1046-PT-CL-0004.
- Enrollment Status: Terminated
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: Pemziviptadil (PB1046) or Placebo
- Sponsor: PhaseBio
- PI: Leslie A. Spikes, MD
REPLACE - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy
A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal.
- Enrollment Status: Completed
- Study Type: Interventional
- PI: Lewis Satterwhite, MD
RIN-PH-201 - INCREASE
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease
- Enrollment Status: Completed
- Study Type: Interventional
- PI: Lewis Satterwhite, MD
RIN-PH-202 - INCREASE OLE
An Open-Label Extension Study of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease
- Enrollment Status: Completed
- Study Type: Interventional
- PI: Lewis Satterwhite, MD
TDE-HF-301 - SouthPaw
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) in Heart Failure with Preserved Ejection Fraction (HFpEF)
- Enrollment Status: Terminated
- Study Type: Interventional
- PI: Lewis Satterwhite, MD
TDE-HF-302 - SouthPaw OLE
An Open-label Extension Study of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) Associated with Heart Failure with Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301
- Enrollment Status: Terminated
- Study Type: Interventional
- PI: Lewis Satterwhite, MD
TIP-PH-101 - BREEZE
An Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects with Pulmonary Arterial Hypertension Currently Using Tyvaso
- Enrollment Status: Completed
- Study Type: Interventional (Clinical Trial)
- Intervention/Treatment: Tyvaso DPITM (Treprostinil Inhalation Powder)
- Sponsor: United Therapeutics
- PI: Leslie A. Spikes, MD
U.S. CTEPH Registry
The U.S. CTEPH Registry is a multicenter, observational, U.S.-based study of the clinical course and treatment of patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), WHO Group IV Classification for Pulmonary Hypertension.
- Enrollment Status: Completed
- Study Type: Observational
- PI: Timothy Williamson, MD, FCCP