A Study of the Efficacy and Safety of MK-5475 in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)
Recruiting
This is a two-part (Phase 2/Phase 3) study of MK-5475, an inhaled soluble guanylate cyclase stimulator, in participants with pulmonary arterial hypertension (PAH). The first part (Phase 2) will assess three different doses of MK-5475 compared to placebo in a base period of 12 weeks, followed by comparison of three different doses of MK-5475 during an optional 24 month extension period. The treatment dose with the best efficacy and safety profile in the phase 2 cohort base period will be selecte... Read More
Gender:
All
Ages:
Between 18 years and 75 years
Trial Updated:
11/23/2023
Locations: Indiana University Health Methodist Hospital ( Site 0045), Indianapolis, Indiana
Conditions: Pulmonary Arterial Hypertension, Hypertension, Pulmonary
A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)
Recruiting
This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).
Gender:
All
Ages:
Between 18 years and 85 years
Trial Updated:
11/23/2023
Locations: IU Health Advanced Heart and Lung Care ( Site 1092), Indianapolis, Indiana +1 locations
Conditions: Hypertension, Pulmonary
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
Recruiting
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.
Gender:
All
Ages:
18 years and above
Trial Updated:
11/17/2023
Locations: St. Vincents Hospital, Indianapolis, Indiana
Conditions: Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus
A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Recruiting
The primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (TPIP) compared with placebo
Gender:
All
Ages:
Between 18 years and 80 years
Trial Updated:
11/16/2023
Locations: USA013, Indianapolis, Indiana
Conditions: Pulmonary Hypertension
Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)
Recruiting
IMPAHCT-FUL: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial is a follow up study to establish the long-term safety of AV-101. The long-term effects of AV-101 on efficacy measures will also be assessed. Subjects who successfully complete the 24-week placebo-controlled parent trial (AV-101-002) will be offered the opportunity to continue into this LTE study. Subjects who enroll in the study will receive one of three active AV-101 doses u... Read More
Gender:
All
Ages:
Between 18 years and 75 years
Trial Updated:
11/13/2023
Locations: Indiana University Health, Indianapolis, Indiana
Conditions: Pulmonary Arterial Hypertension
A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)
Recruiting
IMPAHCT: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the... Read More
Gender:
All
Ages:
Between 18 years and 75 years
Trial Updated:
11/13/2023
Locations: Indiana University Health, Indianapolis, Indiana
Conditions: Pulmonary Arterial Hypertension
Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen
Recruiting
This study is a Phase 2 trial to evaluate the BP-lowering effect of lorundrostat (an ASI), administered as add-on to a standardized AHT medication regimen, in subjects with uncontrolled and/or treatment-resistant hypertension.
Gender:
All
Ages:
18 years and above
Trial Updated:
11/10/2023
Locations: Franciscan Physician Network-Indiana Heart Physicians, Indianapolis, Indiana
Conditions: Hypertension
A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)
Recruiting
This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with pulmonary arterial hypertension (PAH).
Gender:
All
Ages:
Between 1 month and 17 years
Trial Updated:
11/07/2023
Locations: Riley Hospital For Children, Indianapolis, Indiana
Conditions: Pulmonary Arterial Hypertension
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
Recruiting
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.
Gender:
All
Ages:
18 years and above
Trial Updated:
11/07/2023
Locations: Indiana University, Indianapolis, Indiana +1 locations
Conditions: Pulmonary Arterial Hypertension
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
Recruiting
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
Gender:
All
Ages:
18 years and above
Trial Updated:
11/03/2023
Locations: Indiana University School of Medicine, Indianapolis, Indiana +2 locations
Conditions: PAH, Pulmonary Hypertension, Pulmonary Arterial Hypertension, Hypertension, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension, Vascular Diseases, Cardiovascular Diseases, Hypertension, Pulmonary, Lung Diseases, Respiratory Tract Disease
AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension
Recruiting
This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-group (Cohort 2) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension
Gender:
All
Ages:
18 years and above
Trial Updated:
10/23/2023
Locations: Midwest Medical Advisors Inc /ID# 235845, Carmel, Indiana +1 locations
Conditions: Open-angle Glaucoma, Ocular Hypertension
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Recruiting
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
Gender:
All
Ages:
Between 0 years and 20 years
Trial Updated:
09/21/2023
Locations: Riley Hospital for Children at Indiana University, Indianapolis, Indiana
Conditions: Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis; Hemorrhage, Hemophilia, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome