Clinical trials: CORE
Pulmonary Arterial Hypertension
A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE)
The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.
- Trial name
- NCT04712669
- Testing
- rodatristat ethyl 300 mg tablet BID, rodatristat ethyl 600 mg BID
- Where
- 64 sites in United States, Austria and 15 more
- Volunteers
- 108 people
- Sponsor
- Altavant Sciences GmbH
Keratoconjunctivitis Sicca
TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease
This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective…
- Trial name
- CVS (NCT00848198)
- Where
- 10 sites in United States, France and 3 more
- Volunteers
- 314 people, healthy volunteers welcome
- Sponsor
- TearLab Corporation
Rheumatoid Arthritis
An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies
This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche protocol WA18062], NCT00106574 [Roche protocol…
- Trial name
- NCT00720798
- Testing
- Tocilizumab, Disease-modifying anti-rheumatic drugs, Non-steroidal anti-inflammatory drugs
- Where
- 295 sites in United States, Argentina and 32 more
- Volunteers
- 2,067 people
- Sponsor
- Hoffmann-La Roche
Multiple Myeloma
A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody
Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies.
- Trial name
- NCT03525678
- Testing
- Belantamab mafodotin frozen liquid, Belantamab mafodotin lyophilized powder
- Where
- 59 sites in United States, Australia and 6 more
- Volunteers
- 221 people
- Sponsor
- GlaxoSmithKline
Acute Gout
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study
The purpose of the 12-week core study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom…
- Trial name
- β-RELIEVED (NCT01029652)
- Testing
- Canakinumab 150 mg, Triamcinolone acetonide 40 mg
- Where
- 47 sites in Australia, Belgium and 15 more
- Volunteers
- 230 people
- Sponsor
- Novartis Pharmaceuticals
Bone Marrow Biopsy Procedures
Powered Bone Marrow Aspiration and Core Biopsy System Compared to Manual Devices
This is a randomized study evaluating use of a powered bone marrow biopsy and aspiration system (OnControl by Vidacare) compared to traditional manual devices.
- Trial name
- NCT01312519
- Testing
- OnControl Bone Marrow Biopsy and Aspiration System, Manual bone marrow sampling device
- Where
- 2 sites in United States, Spain
- Volunteers
- 50 people
- Sponsor
- Vidacare Corporation
Chronic Lymphocytic Leukemia (CLL)
A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
The purpose of this open-label, single-arm study was to evaluate the impact of venetoclax on the quality of life of participants including those with with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL; a type of…
- Trial name
- VENICE II (NCT02980731)
- Testing
- Venetoclax
- Where
- 33 sites in Argentina, Australia and 8 more
- Volunteers
- 210 people
- Sponsor
- AbbVie
Primary Progressive Multiple Sclerosis
This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.
The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS.
- Trial name
- INFORMS (NCT00731692)
- Testing
- FTY720
- Where
- 157 sites in United States, Australia and 16 more
- Volunteers
- 970 people
- Sponsor
- Novartis Pharmaceuticals
Breast Reconstruction, Breast Augmentation
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- NCT00753922
- Testing
- Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
- Where
- United States
- Volunteers
- 1,008 people
- Sponsor
- Mentor Worldwide, LLC
Juvenile Idiopathic Arthritis
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core Study
This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study.
- Trial name
- NCT01667471
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 3 sites in Germany
- Volunteers
- 6 people
- Sponsor
- Hoffmann-La Roche
Coronary Artery Disease
Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study
The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of…
- Trial name
- NCT02419521
- Testing
- Resolute Onyx Stent - 2.25 mm - 4.0 mm
- Where
- 12 sites in United States
- Volunteers
- 75 people
- Sponsor
- Medtronic Vascular
Chronic Hepatitis B
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B
This primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B.
- Trial name
- NCT00117676
- Testing
- TDF, ADV, FTC/TDF
- Where
- 80 sites in United States, Australia and 13 more
- Volunteers
- 382 people
- Sponsor
- Gilead Sciences
Transfusional Iron Overload, β-thalassemia Major
A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.
In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed.
- Conditions
- Transfusional Iron Overload, β-thalassemia Major, Pediatric Rare Anemia
- Trial name
- NCT00390858
- Testing
- Deferasirox
- Where
- 4 sites in France, Italy
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Gout
A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)
The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating…
- Trial name
- NCT00819585
- Testing
- Canakinumab, Colchicine, Allopurinol
- Where
- 89 sites in United States, Argentina and 16 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
Paget's Disease of the Bone
Re-treatment of Participants With Paget's Disease Using Zoledronic Acid
The purpose of this study was to demonstrate that participants with Paget's disease of the bone who had responded to zoledronic acid treatment as participants in the core registration studies CZOL446K2304 and CZOL446K2305 and…
- Trial name
- NCT00740129
- Testing
- Zoledronic Acid
- Where
- 11 sites in Belgium, Canada and 4 more
- Volunteers
- 6 people
- Sponsor
- Novartis Pharmaceuticals
Leukemia
A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
The extension study followed the core study CAMN107ECN02 (NCT01275196). which is an open-label, two armed study. All patients enrolled in this extension study were able to benefit from the treatment given in CAMN107ECN02 per…
- Trial name
- NCT02272777
- Testing
- Imatinib, Nilotinib
- Where
- 12 sites in China
- Volunteers
- 225 people
- Sponsor
- Novartis Pharmaceuticals
Type 2 Diabetes Mellitus, Cardiovascular Disease
Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)
The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to…
- Trial name
- ALTITUDE (NCT00549757)
- Testing
- Aliskiren
- Where
- 776 sites in United States, Argentina and 35 more
- Volunteers
- 8,606 people
- Sponsor
- Novartis Pharmaceuticals
Genotype 1 Chronic Hepatitis C
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone in Patients With Genotype 1 Chronic Hepatitis C Infection
The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects.
- Trial name
- NCT00606086
- Testing
- GI-5005, Pegylated Interferon and Ribavirin
- Where
- 25 sites in United States
- Volunteers
- 140 people
- Sponsor
- GlobeImmune
Acute Myeloid Leukemia, Myelodysplastic Syndromes
PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2)
CPKC412A2104 core had a 2 stage design. In stage 1, eight participants were treated. If at least one participant showed a clinical response, four more participants were recruited to stage 2.
- Trial name
- NCT00045942
- Testing
- Itraconazole, PKC412
- Where
- 4 sites in United States
- Volunteers
- 144 people
- Sponsor
- Novartis Pharmaceuticals
Retinal Vein Occlusion
Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO
The study is intended to characterize the clinical benefit regarding safety and efficacy of a long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and a 3-month follow-up period, following the…
- Trial name
- NCT01580020
- Testing
- RFB002, Dexamethasone
- Where
- 37 sites in Germany
- Volunteers
- 175 people
- Sponsor
- Novartis Pharmaceuticals