Clinical trials: PATIENT SAFETY
Schizophrenia
A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia
This is a Phase 2, randomized, double-blinded, placebo-controlled, inpatient study to examine the efficacy, safety, and tolerability profile of KarXT in adult subjects diagnosed with DSM-5 schizophrenia who are in an acute…
- Trial name
- EMERGENT-1 (NCT03697252)
- Testing
- Xanomeline and Trospium Chloride Capsules
- Where
- 12 sites in United States
- Volunteers
- 182 people
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Superficial Bladder Cancer
ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC.
- Trial name
- NCT02773849
- Testing
- ADSTILADRIN
- Where
- 34 sites in United States
- Volunteers
- 157 people
- Sponsor
- Ferring Pharmaceuticals
Chronic Pain
Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain
Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic pain.
- Trial name
- NCT00463047
- Testing
- Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
- Where
- 45 sites in United States
- Volunteers
- 323 people
- Sponsor
- Cephalon
Coronary Artery Stenosis
Coronary Laser Atherectomy System for Treatment of Coronary Artery Stenosis (SHINE)
This prospective, multi-center clinical trial evaluates the safety and efficacy of the Coronary Laser Atherectomy System for the pretreatment of coronary artery stenosis.
- Trial name
- SHINE (NCT07697638)
- Testing
- Coronary Laser Atherectomy System, CVX300 Laser System
- Volunteers
- 218 people
- Sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
Hypertension
Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)
Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect.
- Trial name
- NCT01286558
- Testing
- 40 mg telmisartan, 5 mg amlodipine, 80 mg telmisartan
- Where
- 8 sites in Japan
- Volunteers
- 225 people
- Sponsor
- Boehringer Ingelheim
Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV
Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV
The purpose of this study is to determine whether the recombinant human EGF-rP64K/Montanide ISA 51 vaccine is safe, immunogenic and effective in the treatment of stage IIIb/IV non-small-cell lung cancer (NSCLC).
- Trial name
- NSCLC (NCT00516685)
- Testing
- Recombinant Human rEGF-P64K/Montanide Vaccine
- Where
- 10 sites in Malaysia
- Volunteers
- 230 people
- Sponsor
- Bioven Sdn. Bhd.
Metastatic Gastric Cancer
Clinical Study of VG161 Combined With Nivolumab Injection in Patients With Advanced Metastatic Gastric Cancer
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 injection. This study will be conducted in combination with nivolumab injection in HSV seropositive subjects with advanced metastatic gastric or gastroesophageal junction…
- Trial name
- NCT06008925
- Testing
- Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)), Nivolumab Injection
- Where
- China
- Volunteers
- 43 people
- Sponsor
- CNBG-Virogin Biotech (Shanghai) Ltd.
Lymphoma,Non-Hodgkin
Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
The purpose of this study was to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have…
- Trial name
- CHRONOS-3 (NCT02367040)
- Testing
- Copanlisib (Aliqopa, BAY80-6946), Rituximab
- Where
- 187 sites in United States, Argentina and 35 more
- Volunteers
- 458 people
- Sponsor
- Bayer
Moderately to Severely Active Ulcerative Colitis (UC)
Efficacy and Safety of IPG11406 in Moderately to Severely Active Ulcerative Colitis (Phase 2)
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and pharmacokinetics of IPG11406, an investigational oral drug, in adult patients with moderately to severely…
- Trial name
- NCT07535489
- Testing
- IPG11406
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Nanjing Immunophage Biotech Co., Ltd
Metastatic Renal Cell Carcinoma, Metastatic Malignant Melanoma
Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses.
- Trial name
- NCT00625768
- Testing
- AS1409
- Where
- 4 sites in New Zealand, United Kingdom
- Volunteers
- 13 people
- Sponsor
- Antisoma Research
Low Back Pain
Safety, Effectiveness, and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back Pain
The purpose of this open-label, extension study is to characterize the safety, effectiveness, and impact on quality of life measures of long-term repeated dosing of OROS hydromorphone slow release (8, 16, 32 and 64 mg tablets) in…
- Trial name
- NCT00411268
- Testing
- OROS hydromorphone HCI SR (slow release)
- Volunteers
- 207 people
- Sponsor
- Alza Corporation, DE, USA
Melanoma
A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy
This is a Phase II, open-label, randomized, multi-center study to assess the efficacy and safety of IBI363 monotherapy compared to Pembrolizumab in the treatment of patients with unresectable locally advanced or metastatic…
- Trial name
- NCT06797297
- Testing
- IBI363, Pembrolizumab
- Where
- 31 sites in China
- Volunteers
- 180 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Hepatocellular Carcinoma (HCC)
Study of BGB-A317 in Participants With Previously Treated Unresectable HCC
This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma.
- Trial name
- NCT03419897
- Testing
- Tislelizumab
- Where
- 54 sites in China, France and 6 more
- Volunteers
- 249 people
- Sponsor
- BeiGene
Major Depressive Disorder (MDD)
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an…
- Trial name
- NCT01111552
- Testing
- Escitalopram, Aripiprazole
- Where
- 60 sites in United States, Australia and 5 more
- Volunteers
- 237 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Compensated Chronic Hepatitis B
Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B
The purpose of this trial is to provide data of absence of inflammation in patient liver histology after long-term telbivudine treatment and thus help investigators to make a comprehensive judgment on treatment discontinuation in…
- Trial name
- NCT00877149
- Testing
- telbivudine/LDT600
- Where
- 4 sites in China
- Volunteers
- 80 people
- Sponsor
- Novartis Pharmaceuticals
Type 2 Diabetes
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
This is a Phase 1 study, involving a 1-day dosing period, designed to test the safety of investigational study drug ARRY-403 in patients with Type 2 diabetes. Approximately 36 patients from the US will be enrolled in this study.
- Trial name
- NCT00859755
- Testing
- ARRY-403, glucokinase activator; oral
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Array BioPharma
Osteoarthritis, Arthritis, Rheumatoid
Safety and Efficacy of Mobic Inj. (Meloxicam) for the Patients With OA or RA: Observational Study
The main objective of this PMS study was to monitor and assess the safety of Mobic® intramuscular injection (7.5mg ~ 15mg, q.d.) up to 3 days (in case of need for prolonged treatment, switch to Mobic® capsule therapy was…
- Trial name
- NCT00612885
- Where
- 11 sites in South Korea
- Volunteers
- 425 people
- Sponsor
- Boehringer Ingelheim
Lymphoma, Lymphoma, Mantle-Cell
Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Mantle Cell Lymphoma
This is a phase I/II, open-label, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult R/R Mantle Cell Lymphoma subjects
- Conditions
- Lymphoma, Lymphoma, Mantle-Cell, Neoplasms by Histologic Type, Neoplasms
- Trial name
- NCT05155215
- Testing
- IM19 CAR-T cells, Cyclophosphamide, Fludarabine
- Volunteers
- 68 people
- Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
Spinal Cord Injury
Safety Study of GRNOPC1 in Spinal Cord Injury
The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI).
- Trial name
- NCT01217008
- Testing
- GRNOPC1
- Where
- 7 sites in United States
- Volunteers
- 5 people
- Sponsor
- Lineage Cell Therapeutics, Inc.
Glaucoma, Ocular Hypertension
A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).
- Trial name
- NCT01830140
- Testing
- Bimatoprost 0.01%, Bimatoprost 0.03%
- Where
- 2 sites in United States
- Volunteers
- 466 people
- Sponsor
- Allergan