Clinical trials: Tolerability
Hypercholesterolemia
Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)
Primary Objective: To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to…
- Trial name
- NCT02476006
- Testing
- ALIROCUMAB SAR236553 (REGN727), ezetimibe, atorvastatin
- Where
- 153 sites in Austria, Belgium and 14 more
- Volunteers
- 998 people
- Sponsor
- Sanofi
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
The purpose of this study is to determine the effect of TAK-925 after a single intravenous dose (compared to placebo) on promoting wakefulness as measured by sleep latency on the maintenance of wakefulness (MWT) in sleep-deprived…
- Trial name
- NCT03522506
- Testing
- TAK-925, Modafinil
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Takeda
Osteoarthritis, Knee
Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain (0000-057)
The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee pain during a series of timed walks on a treadmill.
- Trial name
- NCT00565084
- Testing
- ibuprofen
- Volunteers
- 33 people
- Sponsor
- Merck Sharp & Dohme LLC
Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell
Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]
The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent /…
- Conditions
- Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell, Gastrointestinal Stroma Tumors
- Trial name
- STAR-TOR (NCT00700258)
- Testing
- Temsirolimus, Sunitinib, Axitinib
- Where
- 77 sites in Germany
- Volunteers
- 1,520 people
- Sponsor
- Pfizer
Gastrointestinal Motility Disorder
A Phase 1, Multiple Intravenous Dose Study to Examine Safety, Tolerability, and PK of Intravenous TD-8954, a 5-HT4 Receptor Agonist, in Healthy Subjects
This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy adults 18 to 45 years of age and healthy…
- Trial name
- NCT01644240
- Testing
- TD-8954
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Small-Cell Lung Cancer
Study of AZD2811 + Durvalumab in ES-SCLC
A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction with Platinum-Based Chemotherapy Combined with…
- Trial name
- TAZMAN (NCT04745689)
- Testing
- Durvalumab, AZD2811, Carboplatin
- Where
- 12 sites in United States, Poland and 2 more
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Chronic Hepatitis C Infection
Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir) administered as two-day monotherapy followed by ABT-267…
- Trial name
- NCT01563536
- Testing
- ABT-267, ABT-450, ABT-333
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Panic Disorder
The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder
The purpose of this study is to determine whether duloxetine is effective in the treatment of panic disorder.
- Trial name
- NCT00438971
- Testing
- Duloxetine
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Massachusetts General Hospital
Glioblastoma, MGMT-Unmethylated Glioblastoma
Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
This Phase I study investigated the side-effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly-diagnosed O6-methylguanine-DNA methyltransferase…
- Trial name
- NCT03250299
- Testing
- Microtubule-Targeted Agent BAL101553, Radiation Therapy
- Where
- 8 sites in United States
- Volunteers
- 26 people
- Sponsor
- Basilea Pharmaceutica
Hypertension With Renal Dysfunction
Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.
- Trial name
- NCT01593787
- Testing
- LCZ696
- Where
- 13 sites in Japan
- Volunteers
- 32 people
- Sponsor
- Novartis Pharmaceuticals
Schizophrenia
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.
- Trial name
- NCT03896945
- Testing
- AVP-786
- Where
- 72 sites in United States, Bulgaria and 2 more
- Volunteers
- 136 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Chikungunya Virus
Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Participants
This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy participants.
- Trial name
- NCT03325075
- Testing
- VAL-181388
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Influenza, Pandemic
A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine in Healthy Adults
The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1014. BW-1014 is a nanoemulsion (NE) adjuvanted recombinant Hemagglutinin 5 (rH5) that would protect against pandemic flu.
- Trial name
- IN-NE-rH5 (NCT05397119)
- Testing
- BW-1014: 25 µg rH5 in 20% NE - pipette - IN, BW-1014: 50 µg rH5 in 20% NE - pipette - IN, BW-1014: 100 µg rH5 in 20% NE - pipette - IN
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- BlueWillow Biologics
Diabetes Mellitus, Type 1
A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.
- Trial name
- NCT02038764
- Testing
- PF-06342674 Dose A, PF-06342674 Dose B, PF-06342674 Dose C
- Where
- 21 sites in United States
- Volunteers
- 37 people
- Sponsor
- Pfizer
Emergency Contraception
Safety and Efficacy of CDB-2914 for Emergency Contraception
The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.
- Trial name
- NCT00411684
- Testing
- CDB-2914
- Where
- 17 sites in United States
- Volunteers
- 1,623 people
- Sponsor
- HRA Pharma
Myelodysplastic Syndromes
A Phase Ib Study Evaluating the Safety and Tolerability of Vitamin C in Patients With Intermediate or High Risk Myelodysplastic Syndrome With TET2 Mutations
This is an open label, Phase Ib study designed to evaluate the safety, toxicity and biological activity of high dose Vitamin C in bone marrow and peripheral blood when administered as therapy to patients with intermediate or high…
- Trial name
- NCT03433781
- Testing
- Vitamin C
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- NYU Langone Health
Vulvovaginal Candidiasis
Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis
This is a multi-center, randomized, double-blind, placebo-controlled study intended to assess the safety, tolerability and humoral and cellular immune response over a 12-month period after receiving one dose of either the NDV-3A…
- Trial name
- NCT01926028
- Testing
- NDV-3A, NDV-3
- Where
- 20 sites in United States
- Volunteers
- 188 people
- Sponsor
- NovaDigm Therapeutics, Inc.
Pain, Postoperative, Dental Pain
A Study of Acetaminophen for Post Surgical Dental Pain
To assess the safety, tolerability, analgesic, efficacy and pharmacokinetics of high dose acetaminophen relative to placebo and low dose acetaminophen relative to placebo over a 24 hour period in patient experiencing moderate to…
- Trial name
- NCT04018612
- Testing
- Acetaminophen
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Nevakar, Inc.
Asthma
BI 443651 Methacholine Challenge
The primary objective of this study is to investigate safety and tolerability of three consecutive administrations, 12 hours apart, at three different dose-levels of BI 443651 administered via oral inhalation in male and female…
- Trial name
- NCT03135899
- Testing
- BI 443651
- Where
- United Kingdom
- Volunteers
- 37 people
- Sponsor
- Boehringer Ingelheim
Prostate Cancer
Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer
RATIONALE: Vaccines made from tumor cells or dendritic cells may help the body build an effective immune response to kill tumor cells. It is not yet known which vaccine is more effective in treating patients with prostate cancer.
- Trial name
- NCT00814892
- Testing
- allogeneic tumor cell vaccine, therapeutic autologous dendritic cells
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Mayo Clinic