Clinical trials: Patient Safety
Ankylosing Spondylitis
Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
The purpose of this study was to assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal…
- Trial name
- NCT02750592
- Testing
- Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.
- Where
- 10 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus, Type 1
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in…
- Trial name
- NCT01194245
- Testing
- Insulin lispro, recombinant human hyaluronidase PH20, Insulin aspart
- Where
- 19 sites in United States
- Volunteers
- 135 people
- Sponsor
- Halozyme Therapeutics
Hepatitis C, Cirrhosis
Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection.
- Conditions
- Hepatitis C, Cirrhosis, Portal Hypertension, With or Without Liver Decompensation
- Trial name
- NCT01687257
- Testing
- SOF, RBV
- Where
- 9 sites in United States, Australia and 3 more
- Volunteers
- 50 people
- Sponsor
- Gilead Sciences
Myelodysplastic Syndrome
An Efficacy and Safety Study of Decitabine in Participants With Myelodysplastic Syndrome (MDS)
The purpose of this study is to evaluate the response rate of decitabine in previously treated and untreated Taiwanese participants with Myelodysplastic Syndrome (MDS - a disease associated with decreased production of blood…
- Trial name
- NCT00744757
- Testing
- Decitabine
- Where
- 6 sites in Taiwan
- Volunteers
- 37 people
- Sponsor
- Johnson & Johnson Taiwan Ltd
Hypertension
MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356)
This study has two parts. In the first part, the efficacy and safety MK-0954E (losartan potassium 50 mg [L50] (+) hydrochlorothiazide 12.5 mg [H12.5] (+) amlodipine besylate 5mg [A5]) will be evaluated and compared to the…
- Trial name
- NCT01299376
- Testing
- L50/H12.5/A5, L50/H12.5
- Volunteers
- 286 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer
A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients
The purpose of this study is to test whether patients with breast cancer who are being treated with non-anthracycline trastuzumab therapy can safely be monitored for heart related side effects less often than usual.
- Trial name
- NCT03983382
- Testing
- Left Ventricular Ejection Fraction
- Where
- 8 sites in United States
- Volunteers
- 190 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Age Related Macular Degeneration
The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) Pilot
Treatment of exudative age-related macular degeneration has been significantly improved by the advent of Lucentis™( which provides improved vision rather than simply stabilization) is common; however, monthly injections may be…
- Trial name
- MAP (NCT00605423)
- Testing
- Fluocinolone Acetonide/Medidur
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Johns Hopkins University
Heart Failure
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction
The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY1067197) when given in addition to appropriate therapy for specific comorbidities.
- Trial name
- PANACHE (NCT03098979)
- Testing
- Neladenoson bialanate (BAY1067197)
- Where
- 76 sites in United States, Austria and 10 more
- Volunteers
- 305 people
- Sponsor
- Bayer
Age-related Macular Degeneration
Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration
The purpose of this study was to evaluate the efficacy and safety of two different brolucizumab 6 mg dosing regimens in patients with visual impairment due to age-related macular degeneration (AMD) who have previously received…
- Trial name
- FALCON (NCT04679935)
- Testing
- Brolucizumab
- Where
- 19 sites in Germany, Switzerland
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus, Type 2
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus
Two independent study parts (i.e. Part A and Part B) are included in this trial. Part A will evaluate empagliflozin 10 mg + linagliptin and Part B will evaluate empagliflozin 25 mg + linagliptin.
- Trial name
- NCT02489968
- Testing
- empagliflozin 10 mg + linagliptin 5 mg, empagliflozin 10 mg, empagliflozin 25 mg + linagliptin 5 mg
- Where
- 83 sites in Japan
- Volunteers
- 880 people
- Sponsor
- Boehringer Ingelheim
Chronic Hepatitis B
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B
This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931.
- Trial name
- NCT03038113
- Testing
- RO7062931, Immune Modulator
- Where
- 19 sites in Australia, Hong Kong and 5 more
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Pseudobulbar Affect (PBA)
Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS
Objectives of the study are to evaluate the safety, tolerability, and efficacy of two different doses of AVP-923 (capsules containing either 30 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate [AVP-923-30] or 20…
- Trial name
- STAR (NCT00573443)
- Testing
- dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg, dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg
- Where
- 62 sites in United States, Argentina and 1 more
- Volunteers
- 326 people
- Sponsor
- Avanir Pharmaceuticals
Rheumatoid Arthritis
A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab [RoActemra/Actemra] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a…
- Trial name
- NCT01089023
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 9 sites in Bahrain, Iran and 3 more
- Volunteers
- 95 people
- Sponsor
- Hoffmann-La Roche
Prostatic Cancer
Quinacrine Treatment in Patients With Androgen-Independent Prostate Cancer
The purpose of this study is to determine whether quinacrine is effective in the treatment of Androgen-Independent Prostate Cancer.
- Trial name
- NCT00417274
- Testing
- Quinacrine
- Volunteers
- 31 people
- Sponsor
- Cleveland BioLabs
Healthy Participants, Narcolepsy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy participants.
- Trial name
- NCT03748979
- Testing
- TAK-925
- Where
- 3 sites in Japan
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Takeda
Multiple Sclerosis Relapse
Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta
The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta…
- Trial name
- TERACLES (NCT01252355)
- Testing
- Teriflunomide, Interferon-beta (IFN-beta)
- Where
- 185 sites in United States, Argentina and 26 more
- Volunteers
- 534 people
- Sponsor
- Sanofi
Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Not Otherwise Specified, Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified
Luspatercept With or Without Hydroxyurea for the Treatment of Myelodysplastic/Myeloproliferative Neoplasms With Ring Sideroblasts and Thrombocytosis or Unclassifiable With Ring Sideroblasts
This phase II trial studies the effects of luspatercept with or without hydroxyurea in treating patients with myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis or unclassifiable with ring…
- Trial name
- NCT05005182
- Testing
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Mayo Clinic
Psoriasis
BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
This is a randomized double blind, double dummy, active comparator controlled, parallel design study that is performed to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) compared to adalimumab to support…
- Trial name
- NCT02694523
- Testing
- risankizumab, adalimumab
- Volunteers
- 684 people
- Sponsor
- AbbVie
Anemia
Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients
This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving about 462 clinically stable hemodialysis patients aged 18 years or above suffering from anemia and treated previously with a stable dose…
- Trial name
- NCT00666835
- Testing
- HX575 epoetin alfa Hexal AG, ERYPO®, Janssen-Cilag
- Where
- 54 sites in Austria, Germany
- Volunteers
- 478 people
- Sponsor
- Sandoz
Heart Failure
Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure
A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function
- Trial name
- STANDUP AHF (NCT03016325)
- Testing
- HNO Donor
- Where
- 116 sites in United States, Argentina and 11 more
- Volunteers
- 329 people
- Sponsor
- Bristol-Myers Squibb
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