Verschiedene PH-Studien
Rehabilitationsklinik Heidelberg – Königstuhl (Studie)
(Spezielles Therapieprogramm für Patienten mit Pulmonal-Arterieller Hypertonie), die in enger Kooperation mit dem Universitätsklinikum Heidelberg durchgeführt wird:
Internet: Koenigstuhl
EARLY
The 185-patient EARLY (Endothelin Antagonist tRial in miLdlY symptomatic PAH patients) study1 was a randomized, double blind, placebo-controlled trial and it is the only randomized controlled trial (RCT) to study a dedicated FCII population.
Significant reduction in pulmonary vascular resistance – Strong trend towards improvement in exercise capacity – Significant delay in time to clinical worsening – Full data analysis ongoing in view of upcoming regulatory filing seeking expansion of the indication.
Unique properties of dual ERA Tracleer® in PAH
Treatment with Tracleer® in 185 mildly symptomatic PAH patients (NYHA modified functional class II) was associated with a highly significant reduction in pulmonary vascular resistance (PVR) compared to placebo (p<0.0001), a primary endpoint of the study. Patients on Tracleer® also showed a strong trend towards improvement in 6-minute-walk test compared to placebo (p=0.076, ns), another primary endpoint. The study met its main secondary endpoint, as treatment with Tracleer® was associated with a significant delay in time to clinical worsening compared to placebo (p=0.018), representing a 70 percent reduction in risk.
BENEFiT
Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension (CTEPH)
BENEFiT study shows Tracleer (bosentan) improves haemodynamics in CTEPH patients refused surgery.
Patients suffering from chronic thromboembolic pulmonary hypertension (CTEPH) who miss out on potentially curative surgery may respond to medical treatment with the dual endothelin receptor antagonist bosentan (Tracleer) according to results of BENEFiT, a multicentre phase III trial presented at this year’s American Thoracic Society meeting. To date there has been no approved medical therapy for the condition.
FREEDOM (Pulmonary Hypertension)
Study Sponsor: CoTherix, Inc
A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled
Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension. TDE-PH-302
Associated with the above Protocol: Protocol TDE-PH-307: An Evaluation of Biomarkers and Genetics in Subjects with Pulmonary Arterial Hypertension Inhibitor in Subjects with Pulmonary Arterial Hypertension. TDE-PH- 301.
Principal Investigator: Dianne Zwicke, MD
MYOGEN 220 EXTENSION
Study Sponsor: Myogen, Inc.
An Open-Label, Long-Term Study of Ambrisentan in Pulmonary Hypertension Subjects Having Completed Myogen Study AMB-220. Protocol No. AMB-220-E
Principal Investigator: Dianne Zwicke, MD
MYOGEN 320/320 E
Study Sponsor: Myogen, Inc
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension“, and AMB 320E: “A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321″.
Principal Investigator: Dianne Zwicke, MD
PHIRST 1 and 2
Study Sponsor: Lilly ICOS LLC
A Randomized, Double Blind, Placebo Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension
Principal Investigator: Dianne Zwicke, MD
PHT VIAGRA
Study Sponsor: Phizer Inc.
A multi-national, multi-center randomized, double-blind, double dummy, placebo controlled study to assess the efficacy and safety of 20, 40, and 80mg tid sildenafil in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over.
Protocol Number: A148-1140
Principal Investigator: Dianne Zwicke, MD
A multi-center, multinational, long-term extension study, to assess the safety and toleration of subject optimized treatment regimens of oral sildenafil for pulmonary arterial hypertension in subjects who have completed Study A1481140.
Protocol Number A1481142
Principal Investigator: Dianne Zwicke, MD
POWER 15 (Evaluation of drug inhalation system)
Study Sponsor: CoTherix, Inc
A Comparison of Safety and Inhalation Times of Iloprost Delivered by I-Neb utilizing Power Disc 6 and Power Disc 15
Principal Investigator: Ramagopal Tumuluri, MD
STRIDE
Study Sponsor: ICOS Corporation
Dose-Finding, Confirmation and Extension Studies of Sitaxentan Sodium to Evaluate its Efficacy in Increasing Exercise Tolerance, Efficacy in Reducing Pulmonary Arterial/Right Ventricular Pressure, Long-Term Safety, and its Pharmacokinetics in Patients with Pulmonary Arterial Hypertension.
Principal Investigator: Dianne Zwicke, MD
PACES
The PACES study (15) examined 267 patients in whom oral sildenafil 20 mg tid titrated to 40 mg and 80 mg tid, as tolerated, at four week intervals given for overall 4 months or placebo was added to established intravenous epoprostenol treatment. The 6-MWD increased by 26 meters (P<0.001). The combination therapy also decreased mPAP to a greater extent (-3.9 mm Hg, P<0.0001). Time to clinical worsening was significantly longer with combination therapy (P=0.012). No patients died during combination therapy versus 7 deaths in the control group.
TRIUMPH I
In the TRIUMPH I study (16) approximately 150 NYHA Class III and IV patients with severe PAH at 14 study sites who are on a stable dose bosentan 125 mg bid. for at least 3 months will be randomized t o either Treprostinil inhalation solution or matching placebo.
VISION
Study Sponsor: CoTherix, Inc
A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients with Pulmonary Arterial Hypertension Receiving Oral Sildenafil
Principal Investigator: Dianne Zwicke, MD
Vision II
Vision II study evaluates the safety and efficacy of the addition of inhaled iloprost in patients with PAH receiving oral sildenafil. The duration is 16 weeks of blinded study drug followed by 32 weeks of open-label iloprost.
COMPASS 1
COMPASS 1 evaluates the effect of a single dose of sildenafil on pulmonary hermodynamics in 45 patients with PAH already being treated with bosentan.
COMPASS 2
COMPASS 2 studies the effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in 600 symptomatic patients with PAH being treated with a stable dose of sildenafil equal to or greater than 20 mg tid for at least 12 weeks prior to randomization. The study duration is 16 weeks, and the primary endpoints are time to clinical worsening and the improvement in 6-MWD.
COMPASS 3
COMPASS 3 is an open-label, multi-center study in 100 patients designed to assess whether a core therapy of bosentan, either as monotherapy or with the addition of sildenafil, enables patients with PAH to achieve a 6 MWD of ≥380 meters after 28 weeks of therapy This design is also appropriate to pioneer the utility of cardiac MRI in assessing improved functional capacity in PAH and exploring its correlation with other parameters.
FUTURE
FormUlation of bosenTan in pUlmonary arterial hypeRtEnsion
This was a phase III open label, single-arm study4 of a novel pediatric formulation to characterize the pharmacokinetic profile in children with PAH. The pediatric formulation of bosent a n was well tolerated with a safety profile similar to that seen previously in the adult population. The longer-term safety and efficacy continues to be studied in the FUTURE-2 extension study.
Übersicht der zur Zeit offenen „pulmonale Hypertonie“ Studien gem. clicialtrials.gov (Januar 2007)
Internet: clinicaltrials – Studien (en)
