Clinical trials: Low Dose
Dyslipidemia, Healthy Volunteers
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia.
- Trial name
- NCT01487460
- Testing
- TAP311
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
A Study Comparing Immunopheresis® Alone or In Combination With Chemotherapy Versus Chemotherapy Alone in Treatment of Advanced Breast Cancer Patients
This is a multicenter, open-label, Phase 1/ 2 study to evaluate the short-term and longer-term safety, tolerability, and effectiveness of Immunopheresis® with the LW-02 column in removal of Soluble Tumor Necrosis Factor Receptors…
- Trial name
- NCT04004910
- Testing
- Plasma soluble TNF receptor pulldown, Plasma soluble TNF receptor pulldown + chemotherapy, Chemotherapy Drugs, Cancer
- Where
- 5 sites in Poland, Turkey (Türkiye)
- Volunteers
- 170 people
- Sponsor
- Immunicom Inc
LDL Cholesterol
Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction
Study to assess the LDL-C lowering efficacy of different doses of LIB003 administered every 4 weeks in subjects on stable statin and/or ezetimibe therapy
- Trial name
- NCT03549260
- Testing
- LIB003
- Where
- 5 sites in United States
- Volunteers
- 81 people
- Sponsor
- LIB Therapeutics LLC
Myelodysplastic Syndromes
Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes
Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients with low or intermediate-1 risk myelodysplastic syndromes…
- Trial name
- NCT02240706
- Testing
- Best Supportive Care, BI 836858
- Where
- 5 sites in United States, Germany
- Volunteers
- 27 people
- Sponsor
- Boehringer Ingelheim
Myelodysplastic Syndromes
Dose Escalation and Proof-of-Concept Studies of Vactosertib (TEW-7197) Monotherapy in Patients With MDS
This is a prospective, open-label, multicenter, phase 1/2 study of TEW-7197 in patients with low and intermediate risk of myelodysplastic syndrome (MDS).
- Trial name
- NCT03074006
- Testing
- TEW-7197
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- MedPacto, Inc.
Muscle Recovery
Investigating the Efficacy of Low or High Dose Tart Cherry on Recovery From Exercise Induced Muscle Damage and Establishing Its Molecular Mechanisms of Action
To determine the dose-response effects of 10-day tart cherry product consumption (0, 30 ml, and 60 ml) on knee extensor isometric strength 24-h and 48-h after muscle damaging exercise and to elucidate the mechanisms of action for…
- Trial name
- NCT04725149
- Testing
- 500 ml base solution, 500 ml containing 30 ml tart cherry concentrate diluted with water and base solution, 500 ml containing 60 ml tart cherry concentrate diluted with water only
- Where
- United Kingdom
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Menopause, Postmenopausal Vaginal Atrophy
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.
- Trial name
- NCT00431132
- Testing
- estradiol, 10 mcg
- Where
- 42 sites in Czechia, Denmark and 5 more
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Post-operative Pain
Post-operative Efficacy and Safety Study
The purpose of this study was to compare the analgesic efficacy of 5 mg oxymorphone IR with placebo in patients with mild to moderate pain following outpatient knee arthroscopy.
- Trial name
- NCT00904085
- Testing
- Oxymorphone IR
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Melanoma (Skin)
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
RATIONALE: Vaccines made from a person's white blood cells combined with melanoma antigens may make the body build an immune response to tumor cells.
- Trial name
- NCT00004025
- Testing
- aldesleukin, dendritic cell-gp100-MART-1 antigen vaccine
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Genzyme, a Sanofi Company
Multiple Myeloma, Recurrent or Refractory
A Study of the Efficacy and Safety of Pomalidomide Capsules Combined With Low-Dose Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
The purpose of this study is to evaluate the efficacy and safety of permadomide capsules developed by Qilu Pharmaceutical Co., LTD.
- Trial name
- NCT05236621
- Testing
- Pomalidomide, Dexamethasone
- Where
- 23 sites in China
- Volunteers
- 85 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Neutropenia (Low White Blood Cell Count)
A Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Tolerability of Filgrastim Biosimilar and Neupogen Reference Product in Healthy Volunteers
The goal of this clinical trial is to assess the pharmacokinetic similarity of Biofilgragen, a filgrastim biosimilar, compared with EU-authorized Neupogen after single subcutaneous doses in healthy adult volunteers.
- Trial name
- FIL-BIO-IMG (NCT07877467)
- Testing
- Biofilgragen, Neupogen (filgrastim)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- BioGeneric Pharma
Postoperative Pain
Double Blind Efficacy and Safety Study of Flexible-Dose vs Low-Dose Q8003 After Undergoing Primary Unilateral Total Knee Arthroplasty
This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients who have undergone primary unilateral total knee arthroplasty
- Trial name
- NCT01055015
- Testing
- Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride), Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)
- Where
- 11 sites in United States
- Volunteers
- 141 people
- Sponsor
- QRxPharma Inc.
Chronic Kidney Disease, Diabetic Nephropathy
Evaluate the Efficacy and Safety of Once Daily Administration of Atrasentan Tablets (Low and High) Compared to Placebo in Reducing Residual Albuminuria in Type 2 Diabetic Patients With Nephropathy Who Are Treated With the Maximum Tolerated Labeled Dose of a Renin Angiotensin System (RAS) Inhibitor
Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study. The objective of the study is to evaluate the efficacy and safety of once daily administration of atrasentan tablets (low dose and high dose) compared…
- Trial name
- RADAR (NCT01356849)
- Testing
- Atrasentan
- Where
- 72 sites in United States, Canada and 2 more
- Volunteers
- 149 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Diffuse Large B-Cell Lymphoma
A Study of DPX-Survivac Vaccine Therapy in Patients With Recurrent Survivin-expressing DLBCL
This phase 2 study was designed to assess the efficacy and safety of DPX-Survivac plus low dose cyclophosphamide in up to 24 subjects with recurrent diffuse large B-cell lymphoma (DLBCL) who are not eligible for transplant.
- Trial name
- NCT02323230
- Testing
- DPX-Survivac, Cyclophosphamide
- Where
- 2 sites in Canada
- Volunteers
- 4 people
- Sponsor
- ImmunoVaccine Technologies, Inc. (IMV Inc.)
Non-muscle Invasive Bladder Cancer
CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON)
The study consisted of 2 sequential parts. Part A assessed the safety and tolerability of CAVATAK administered via intravesical instillation in patients with non-muscle invasive bladder cancer scheduled to undergo TUR.
- Trial name
- CANON (NCT02316171)
- Testing
- CVA21, Mitomycin C
- Where
- United Kingdom
- Volunteers
- 16 people
- Sponsor
- Viralytics
Gastric Ulcer, Duodenal Ulcer
A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Low-Dose Aspirin Therapy
The purpose of this study is to study the safety and efficacy of TAK-438, once daily (QD), in participants with a history of gastric or duodenal ulcer requiring long-term low-dose aspirin therapy will be investigated.
- Trial name
- NCT01568398
- Testing
- TAK-438
- Where
- 19 sites in Japan
- Volunteers
- 27 people
- Sponsor
- Takeda
Hypercholesterolemia
Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet therapy alone or the lowest…
- Trial name
- ODYSSEY-NIPPON (NCT02584504)
- Testing
- Alirocumab, Atorvastatin, Non-statin Lipid-Modifying Therapy
- Where
- 30 sites in Japan
- Volunteers
- 163 people
- Sponsor
- Sanofi
Coronary Arteriosclerosis, Diabetes Mellitus, Type 2
Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)
Physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol.
- Conditions
- Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia
- Trial name
- ACTFAST (NCT00442845)
- Testing
- Atorvastatin (Lipitor)
- Where
- 121 sites in Cameroon, Canada and 3 more
- Volunteers
- 2,080 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Multiple Myeloma
Anti-CXCR4 (BMS-936564) Alone and in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma
The purpose of this study is to determine 1) the safety and tolerability of multiple intravenous doses of anti-CXCR4 (BMS-936564) as monotherapy and as combination, and 2) the maximum tolerated dose (MTD) of BMS-936564 in…
- Trial name
- NCT01359657
- Testing
- Anti-CXCR4 (BMS-936564), Lenalidomide, Dexamethasone
- Where
- 4 sites in United States
- Volunteers
- 46 people
- Sponsor
- Bristol-Myers Squibb
Cancer
Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations
This was a 4-part (Part A, Part B, Part C and Part D), Phase I/IIa, multi-center, open label, study in pediatric subjects with refractory or recurrent tumors.
- Trial name
- NCT02124772
- Testing
- Trametinib, Dabrafenib
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 139 people
- Sponsor
- Novartis Pharmaceuticals