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Completed Pulmonary Hypertension Trials

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, M.D.

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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, M.D.

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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, M.D.

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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, M.D.

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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, M.D.

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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.

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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

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RIN-PH-202 - INCREASE OLE

An Open-Label Extension Study of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease

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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)

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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

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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

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Internal Medicine

University of Kansas Medical Center
Internal Medicine
Pulmonary, Critical Care, and Sleep Medicine Division
Mailstop 3007
3901 Rainbow Boulevard
Kansas City, KS 66160
Phone: 913-588-6045