Clinical trials: Medication Safety
Solid Tumor
Phase I Study of SYD985 With Niraparib in Patients With Solid Tumors
SYD985.004 is a two-part phase I study with the antibody-drug conjugate SYD985 in combination with niraparib aimed at evaluating safety, pharmacokinetics and efficacy in patients with HER2-expressing locally advanced or…
- Trial name
- NCT04235101
- Testing
- SYD985 + Niraparib
- Where
- 6 sites in Belgium, Netherlands and 1 more
- Volunteers
- 32 people
- Sponsor
- Byondis B.V.
Spasticity
MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity
This study is a randomized, double blind, multi-center, active drug controlled, phase III clinical trial to compare the efficacy and safety of MEDITOXIN® versus BOTOX® in treatment of post stroke upper limb(wrist, finger, thumb)…
- Trial name
- NCT01313767
- Testing
- Botulinum toxin type A
- Where
- South Korea
- Volunteers
- 196 people
- Sponsor
- Medy-Tox
Acute Depressive Episode
Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder
The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily (QD), sublingual (SL), in adult participants with acute depressive episodes associated with Bipolar I disorder.
- Trial name
- NCT01467700
- Testing
- Ramelteon SL
- Where
- 161 sites in United States, Argentina and 3 more
- Volunteers
- 490 people
- Sponsor
- Takeda
Schizophrenia, Schizophrenic Disorders
Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.
The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.
- Conditions
- Schizophrenia, Schizophrenic Disorders, Psychotic Disorders, Dementia Praecox
- Trial name
- NCT00488319
- Testing
- Paliperidone ER
- Where
- 53 sites in United States, Belgium and 9 more
- Volunteers
- 400 people
- Sponsor
- Janssen Research & Development, LLC
HIV
TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.
The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with…
- Trial name
- NCT00258557
- Testing
- LPV/RTV, TMC-114/RTV
- Where
- 89 sites in United States, Argentina and 23 more
- Volunteers
- 692 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Chronic Renal Failure
rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics
The study is a single center and open test, and the dose of successive incremental method was taken. In order to determine the tolerance and safety after a single intravenous injection of different doses of rESP in healthy…
- Trial name
- NCT02356419
- Testing
- Recombinant erythropoietin stimulating protein
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Vytorin Reexamination Study (0653A-174)
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting…
- Trial name
- NCT01070966
- Volunteers
- 2,089 people
- Sponsor
- Organon and Co
Pulmonary Arterial Hypertension
Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of Treprostinil
Acute and chronic hemodynamic dose-response and safety evaluation of LIQ861 in PAH subjects.
- Trial name
- NCT03884465
- Testing
- Inhaled dry powder treprostinil (LIQ861)
- Where
- 3 sites in France, Germany
- Volunteers
- 15 people
- Sponsor
- Liquidia Technologies, Inc.
Bladder Neoplasm, Neoplasm Recurrence, Local
Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide.
- Conditions
- Bladder Neoplasm, Neoplasm Recurrence, Local, Transitional Cell, Carcinoma, Carcinoma in Situ
- Trial name
- EMBARC-RF (NCT01200992)
- Testing
- EN3348, Mitomycin C
- Where
- 72 sites in United States, Canada and 4 more
- Volunteers
- 84 people
- Sponsor
- Bioniche Life Sciences Inc.
Multiple Myeloma
A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments
The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab…
- Trial name
- MAGNETISMM-5 (NCT05020236)
- Testing
- Elranatamab, Daratumumab, Pomalidomide
- Where
- 237 sites in United States, Argentina and 24 more
- Volunteers
- 893 people
- Sponsor
- Pfizer
Pain, Nausea
A Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route
The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo…
- Conditions
- Pain, Nausea, Vomiting
- Trial name
- NCT02712554
- Testing
- CL-108, M366
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Charleston Laboratories, Inc
Type 2 Diabetes Mellitus
Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)
Primary Objectives: The co-primary objective of this study is: To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) versus lixisenatide on glycemic control as assessed by…
- Trial name
- Lixilan-O-AP (NCT03798054)
- Testing
- Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Lixisenatide (AVE0010)
- Where
- 79 sites in China, Malaysia and 2 more
- Volunteers
- 878 people
- Sponsor
- Sanofi
HIV Infections
The Safety and Effectiveness of Fozivudine Tidoxil in HIV-1 Infected Patients
To identify doses of fozivudine tidoxil that are well tolerated and produce measurable antiviral activity. To identify the adverse event profile that defines the maximum tolerated dose.
- Trial name
- NCT00002385
- Testing
- Fozivudine tidoxil
- Volunteers
- 60 people
- Sponsor
- Anderson Clinical Research
COVID-19 Infection
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone…
- Trial name
- NCT07013474
- Testing
- ibuzatrelvir, remdesivir
- Where
- 159 sites in United States, Argentina and 16 more
- Volunteers
- 300 people
- Sponsor
- Pfizer
Erosive Esophagitis
Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis
The purpose of this study is to determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.
- Trial name
- NCT01452776
- Testing
- TAK-438
- Where
- 32 sites in Japan
- Volunteers
- 305 people
- Sponsor
- Takeda
Crohn's Disease
A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease
This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China.
- Trial name
- NCT05837897
- Testing
- Vedolizumab IV
- Where
- 41 sites in China
- Volunteers
- 408 people
- Sponsor
- Takeda
Diabetes, Diabetes Mellitus, Type 2
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes
This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes. (SUSTAIN™ 1-Monotherapy).
- Trial name
- SUSTAIN™1 (NCT02054897)
- Testing
- semaglutide
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 388 people
- Sponsor
- Novo Nordisk A/S
Healthy Participants
Study to Evaluate the Effect of Rifampin on the Drug Levels in Blood and Safety of BMS-986235 in Healthy Participants
The purpose of this study is to examine the effect of rifampin on the drug levels in blood and safety of BMS-986235, when taken by healthy participants.
- Trial name
- NCT04301310
- Testing
- BMS-986235 (Treatment A), Rifampin (Treatment B)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Type 2 Diabetes
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes
The main purpose of this study is to evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in Japanese participants with type 2 diabetes.
- Trial name
- NCT02750410
- Testing
- Dulaglutide
- Where
- 25 sites in Japan
- Volunteers
- 159 people
- Sponsor
- Eli Lilly and Company
Healthy
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fed condition in healthy volunteers.
- Trial name
- NCT06357910
- Testing
- HCP2303, RLD2302, RLD2102
- Where
- South Korea
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited