Clinical trials: Medication Safety
HIV Infections
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.
- Trial name
- NCT02362503
- Testing
- BMS-663068
- Where
- 139 sites in United States, Argentina and 23 more
- Volunteers
- 371 people
- Sponsor
- ViiV Healthcare
Hyperlipidemia
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density…
- Trial name
- MENDEL-2 (NCT01763827)
- Testing
- Evolocumab, Ezetimibe
- Where
- 83 sites in United States, Australia and 8 more
- Volunteers
- 615 people
- Sponsor
- Amgen
Fungal Infection
Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)
The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of a 12-week treatment with Posaconazole Oral Suspension in participants with IFI
- Trial name
- NCT00811642
- Testing
- Posaconazole
- Volunteers
- 63 people
- Sponsor
- Merck Sharp & Dohme LLC
Tourette's Disorder
ABF Tourette's Disorder Post Marketing Surveillance Study
This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA Notification No. 2010-94 dated 27 December 2010).
- Trial name
- NCT01795105
- Where
- 4 sites in South Korea
- Volunteers
- 692 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Schizophrenia
A Phase 2 Efficacy and Safety Study of TAK-063 in Participants With an Acute Exacerbation of Schizophrenia
The purpose of this study is to evaluate the efficacy, safety and tolerability of TAK-063 compared with placebo in treatment of acutely exacerbated schizophrenia.
- Trial name
- NCT02477020
- Testing
- TAK-063 20 mg
- Where
- 15 sites in United States
- Volunteers
- 164 people
- Sponsor
- Takeda
Healthy Volunteers
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 2 of 4)
The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.
- Trial name
- NCT03578146
- Testing
- PRT064445/Rivaroxaban
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Healthy Volunteers
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 4 of 4)
The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.
- Trial name
- NCT03551743
- Testing
- PRT064445/Edoxaban
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Pain, Quality of Life
FLUAD® vs. Fluzone® High-Dose Study
The overall aim of the study is to compare safety and immunogenicity of inactivated influenza vaccine (IIV), adjuvanted (FLUAD®) versus High-Dose inactivated influenza (Fluzone® High-Dose) vaccine in persons ≥65 years (20% aged…
- Conditions
- Pain, Quality of Life, Injection Site Reaction, Side Effect of Drug
- Trial name
- NCT03183908
- Testing
- FLUAD®, Fluzone® High-Dose
- Where
- 4 sites in United States
- Volunteers
- 757 people, healthy volunteers welcome
- Sponsor
- Duke University
Crohn's Disease, Complex Perianal Fistula
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.
- Trial name
- NCT04075825
- Testing
- Darvadstrocel
- Where
- 58 sites in United States, Belgium and 7 more
- Volunteers
- 150 people
- Sponsor
- Takeda
Coronary Artery Disease, Atherosclerosis, Coronary
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOFLOW-VII (NCT04175626)
- Testing
- Orsiro DES
- Where
- 33 sites in United States
- Volunteers
- 556 people
- Sponsor
- Biotronik, Inc.
Migraine
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
This study will evaluate the potential for a pharmacokinetic (PK) interaction and provide safety and tolerability information when ubrogepant and erenumab or ubrogepant and galcanezumab are co-administered.
- Trial name
- NCT04179474
- Testing
- Ubrogepant, Erenumab, Galcanezumab
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Allergan
Essential Tremor
Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with…
- Trial name
- NCT02289560
- Testing
- Transcranial ExAblate
- Where
- 7 sites in United States
- Volunteers
- 61 people
- Sponsor
- InSightec
Diabetes, Diabetes Mellitus, Type 2
A Trial Comparing Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other Oral Antidiabetic Drug (OAD)
This trial is conducted in Asia. The aim of this trial is to confirm the superiority of insulin degludec/liraglutide versus insulin degludec in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus after 26…
- Trial name
- DUAL™ II China (NCT03175120)
- Testing
- Insulin degludec/liraglutide, Insulin degludec
- Where
- 37 sites in China, Hong Kong
- Volunteers
- 453 people
- Sponsor
- Novo Nordisk A/S
Healthy, Aging
Ashwagandha Pharmacokinetics Study in Older Adults
This study will measure the oral bioavailability and pharmacokinetics of known compounds from a standardized Withania somnifera botanical dietary supplement in healthy older adults.
- Trial name
- NCT06171724
- Testing
- Shoden
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Adverse Drug Events
Implementation of Real-time ADE Surveillance and Decision Support
The purpose of this study is to determine if an electronic alerting technology improves time to intervention for possible ADEs, identify what factors affect adoption of ADE alerts, and whether there is a cost benefit associated…
- Trial name
- VA ADE (NCT00780572)
- Testing
- ADE alert assistant
- Where
- United States
- Volunteers
- 595 people
- Sponsor
- VA Office of Research and Development
Osteoarthritis, Knee, Osteoarthritis, Hip
Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip.
- Trial name
- FACT OA2 (NCT03304379)
- Testing
- Fasinumab, Diclofenac, Celecoxib
- Where
- 71 sites in United States
- Volunteers
- 1,650 people
- Sponsor
- Regeneron Pharmaceuticals
Plaque Psoriasis
A Trial of a Botanical Drug (EISO) for Treatment of Mild-to-Moderate Plaque Psoriasis
This trial will be a double-blind, multi-center, randomized, placebo controlled study to evaluate the safety, tolerability, and efficacy of SAN021 study drug when administered for up to 42 days to adults between the ages of 18 to…
- Trial name
- NCT03000608
- Testing
- SAN021 Serum
- Where
- 4 sites in United States
- Volunteers
- 69 people
- Sponsor
- Santalis Pharmaceuticals, Inc.
Multiple Myeloma
An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD
The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor [PI]…
- Trial name
- NCT01985126
- Testing
- Daratumumab 16 mg/kg (Part 1), Daratumumab 8 mg/kg (Part 1), Methylprednisolone
- Where
- 23 sites in United States, Canada and 1 more
- Volunteers
- 124 people
- Sponsor
- Janssen Research & Development, LLC
Pain
An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache
Headaches affect over 50% of patients annually, with close to 4% of ED visits for headache. Most headaches managed in the ED are benign, with 90% of these headaches classified as tension, migraine, or cluster.
- Trial name
- NCT04860713
- Testing
- aspirin and ketamine, Nurtec (Rimegepant)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Antonios Likourezos
Rheumatoid Arthritis
A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis
The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in patients with active rheumatoid arthritis (RA)…
- Trial name
- NCT00993317
- Testing
- CDP870 200mg, Methotrexate
- Where
- 15 sites in South Korea
- Volunteers
- 127 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
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