Clinical trials: High-risk Medications
Cardiovascular Diseases
Efficacy Study of Pioglitazone and Atorvastatin Combination Therapy in Treating Subjects With Elevated Risk for Cardiovascular Disease
The purpose of this study is to determine the effect of pioglitazone, once daily (QD), and atorvastatin combination therapy compared to atorvastatin monotherapy in patients at risk for cardiovascular disease.
- Trial name
- NCT00770575
- Testing
- Pioglitazone and atorvastatin, Atorvastatin
- Volunteers
- 148 people
- Sponsor
- Takeda
Stable Angina, Ischemic Heart Disease Silent
A Randomized Clinical Evaluation of the BioFreedom™ Stent
The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and…
- Conditions
- Stable Angina, Ischemic Heart Disease Silent, ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction, In-stent Coronary Artery Restenosis
- Trial name
- Leaders Free (NCT01623180)
- Testing
- Biofreedom™ Drug Coated Stent (DCS), Gazelle™ Bare Metal Coronary Stent (BMS)
- Where
- Switzerland
- Volunteers
- 2,456 people
- Sponsor
- Biosensors Europe SA
Prostatic Neoplasms, Neoplasm Metastasis
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)
The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.
- Conditions
- Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms, Physiological Effects of Drugs
- Trial name
- CYCLONE 3 (NCT05288166)
- Testing
- Abemaciclib, Abiraterone, Prednisone or Prednisolone
- Where
- 266 sites in United States, Argentina and 22 more
- Volunteers
- 925 people
- Sponsor
- Eli Lilly and Company
Drug/Agent Toxicity by Tissue/Organ, Pancreatic Cancer
Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.
- Trial name
- NCT00024427
- Testing
- fluorouracil, gemcitabine hydrochloride, triacetyluridine
- Where
- 29 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Wellstat Therapeutics
Hypertension
Effectiveness and Tolerability of Tarka® in the Treatment of Hypertensive Patients With High Risk of Developing Diabetes Mellitus
The aim of this post-marketing observational study (PMOS) is to provide data on the effectiveness and tolerability of Tarka in patients with a high risk of developing diabetes mellitus, as prescribed by the physicians in a…
- Trial name
- TARDIA (NCT01079195)
- Where
- 898 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 15,436 people
- Sponsor
- Abbott
Asthma, Asthma, Bronchial
Mechanistic Study of Anti-inflammatory Effects of Fevipiprant in Patients With Eosinophilic Asthma.
This is an exploratory, randomized, subject- and investigator-blinded, placebo-controlled mode-of-action study to demonstrate the anti-inflammatory effects of fevipiprant compared to placebo after 12 weeks of treatment in 48…
- Conditions
- Asthma, Asthma, Bronchial, Bronchial Asthma, Eosinophilia
- Trial name
- NCT03989635
- Testing
- QAW039
- Sponsor
- Novartis Pharmaceuticals
Hypertension, Pulmonary
This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
In this trial the effects of the inhaled drug BAY1237592 will be studied in patients with high blood pressure in the pulmonary blood vessels due to Pulmonary Arterial Hypertension (PAH) and due to Chronic Thromboembolic Pulmonary…
- Trial name
- ATMOS (NCT03754660)
- Testing
- BAY1237592
- Where
- 8 sites in Austria, Czechia and 2 more
- Volunteers
- 38 people
- Sponsor
- Bayer
Disease, Hodgkin
A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)
This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of…
- Trial name
- NCT01100502
- Testing
- brentuximab vedotin
- Where
- 87 sites in United States, Bulgaria and 11 more
- Volunteers
- 329 people
- Sponsor
- Seagen Inc.
Schizophrenia
SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.
- Trial name
- NCT01760889
- Testing
- SPD489 low dose range (40mg, 80mg, and 100mg), SPD489 high dose range (120mg, 140mg and 160mg)
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Shire
Healthy Volunteers
A Study in Healthy Participants Investigating Biomarkers After Exposure to Heparin When Heparin is Administered in the Fasted State or After a High-fat Meal. Heparin, a Registered Drug, is an Anticoagulant (Blood Thinner) That Prevents the Formation of Blood Clots.
In this study biomarkers in the blood after exposure to heparin in the fasted state or after a high-fat meal will be investigated.
- Trial name
- NCT05178550
- Testing
- Heparin
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Urinary Bladder Neoplasms
A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder
A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.
- Trial name
- CheckMate 9UT (NCT03519256)
- Testing
- Nivolumab, BCG, BMS-986205
- Where
- 88 sites in United States, Argentina and 13 more
- Volunteers
- 142 people
- Sponsor
- Bristol-Myers Squibb
High Risk Coronary Artery Disease
A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (What Does the Body Does to the Drug) of Rosuvastatin to Measure the Relative Bioavailability (the Extent to Which a Drug or Other Substance Becomes Available to the Body) of AZD5718 Oral Suspension vs AZD5718 Immediate Release Tablet
This study is a randomized, open-label, 5-period, 5-treatment, single-dose, single-center, crossover study to estimate the effect of AZD5718 on the pharmacokinetics (PK) of rosuvastatin, and to assess the relative bioavailability…
- Trial name
- NCT02963116
- Testing
- AZD5718 IR tablet, AZD5718 oral suspension, Rosuvastatin tablet
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Refractory Partial Seizures
An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)
The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese patients with refractory partial seizures which are uncontrolled with other anti-epileptic drugs (AEDs).
- Trial name
- NCT00849212
- Testing
- E2007
- Where
- 9 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Eisai Co., Ltd.
Healthy Volunteers, Dyslipidaemia
A Study to Look at How Safe a New Medicine (NNC0491-6075) is in Healthy People and in Participants With High Levels of Fat in the Blood
The study is testing a new study medicine to treat people with high levels of fat in the blood. The main aim of the study is to see if the new study medicine is safe and how it works in the body.
- Trial name
- NCT05979428
- Testing
- NNC0491-6075
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Early Breast Cancer, Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-)
A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer
This Phase 3 study will evaluate whether atirmociclib plus giredestrant improves invasive breast cancer-free survival compared with giredestrant alone in adults with ER-positive, HER2-negative early breast cancer at medium or…
- Trial name
- NCT07890597
- Testing
- Atirmociclib, giredestrant
- Volunteers
- 3,800 people
- Sponsor
- Pfizer
End-stage Renal Disease, Prevention of Thromboembolic Events
Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis
In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins…
- Conditions
- End-stage Renal Disease, Prevention of Thromboembolic Events, Hemodialysis, Hemodiafiltration
- Trial name
- CONVERT (NCT04523220)
- Testing
- BAY1213790 (Osocimab)
- Where
- 151 sites in United States, Australia and 17 more
- Volunteers
- 704 people
- Sponsor
- Bayer
Coronary Artery Lesions
XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.
XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary…
- Trial name
- NCT03218787
- Testing
- XIENCE, DAPT
- Where
- 101 sites in United States
- Volunteers
- 2,047 people
- Sponsor
- Abbott Medical Devices
High Grade Glioma (III or IV), Diffuse Midline Glioma (DMG)
A Phase I Study of FZ-AD005 in Patients With High-Grade Glioma (HGG)
An Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with HGG, especially in DMG and other Recurrent HGG.
- Conditions
- High Grade Glioma (III or IV), Diffuse Midline Glioma (DMG), Glioblastoma (GBM)
- Trial name
- NCT07455045
- Testing
- FZ-AD005
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Major Depressive Disorder
Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology
The purpose of this study was to evaluate the feasibility and compliance with a novel method for assessing mood and cognition in participants with major depressive disorder (MDD).
- Trial name
- NCT03067506
- Testing
- No intervention
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Takeda
Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic
Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine.
- Conditions
- Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Trial name
- PANTHER (NCT03268954)
- Testing
- Azacitidine, Pevonedistat
- Where
- 242 sites in United States, Australia and 18 more
- Volunteers
- 454 people
- Sponsor
- Takeda