Clinical trials: Patient Safety
Long QT Syndrome
Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 2 or 3 Long QT Syndrome (Part 2).
Part 1: This is a Phase 1b, randomized, double-blind, crossover, dose escalation, placebo-controlled study to evaluate the effect of oral LQT-1213 on dofetilide-induced QTc prolongation in healthy adult subjects.
- Trial name
- NCT05906732
- Testing
- LQT-1213, Dofetilide 250 μg Cap
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Thryv Therapeutics, Inc.
Carcinoma, Carcinoma, Renal Cell
Savolitinib vs. Sunitinib in MET-driven PRCC.
This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma.
- Conditions
- Carcinoma, Carcinoma, Renal Cell, Kidney Neoplasms, Urologic Neoplasms
- Trial name
- NCT03091192
- Testing
- Savolitinib, Sunitinib
- Where
- 59 sites in United States, Brazil and 5 more
- Volunteers
- 60 people
- Sponsor
- AstraZeneca
Ewing's Sarcoma
A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma
A two-part trial in patients with metastic Ewing's sarcoma. Participants in Part 1 will be randomized to receive either Vigil immunotherapy or gemcitabine and docetaxel with the objective of comparing the overall survival between…
- Trial name
- NCT02511132
- Testing
- Vigil, Temozolomide, Irinotecan
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Gradalis, Inc.
Freidreich's Ataxia
Long-Term Safety and Tolerability of Idebenone in Friedreich's Ataxia Patients (MICONOS Extension)
This is an Extension study of the MICONOS main randomised placebo-controlled trial (NCT00905268), and open to those patients completing the main study.
- Trial name
- NCT00993967
- Testing
- idebenone
- Where
- 11 sites in Austria, Belgium and 3 more
- Volunteers
- 200 people
- Sponsor
- Santhera Pharmaceuticals
Chronic Kidney Disease, Chronic Renal Failure
A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose requirements in patients treated for anemia associated…
- Trial name
- AiME - 01 (NCT01473407)
- Testing
- Epoetin Hospira, Epogen (Amgen)
- Where
- 85 sites in United States, Puerto Rico
- Volunteers
- 612 people
- Sponsor
- Pfizer
Metastatic Pancreatic Adenocarcinoma
Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer
Gemcitabine and nab-paclitaxel is a standard regimen (NCCN, Category 1) for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). However, further improvement in treatment is needed.
- Trial name
- NCT02562898
- Testing
- Ibrutinib, Paclitaxel, Gemcitabine
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Margaret Tempero
Metastatic Breast Cancer, HER2+ Breast Cancer
Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer
This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab.
- Trial name
- NCT01132664
- Testing
- BKM120, Trastuzumab, Capecitabine
- Where
- 21 sites in United States, Belgium and 4 more
- Volunteers
- 72 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension
Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)
The purpose of this study is to evaluate the effect of zilebesiran on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of zilebesiran as add-on therapy.
- Trial name
- KARDIA-2 (NCT05103332)
- Testing
- Indapamide, Amlodipine, Olmesartan
- Where
- 110 sites in United States, Canada and 6 more
- Volunteers
- 663 people
- Sponsor
- Alnylam Pharmaceuticals
Myelodysplastic Syndrome
Long Term Safety Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study
This is an extension study to investigate long term safety and efficacy of SyB C-1101 when orally administered every 3 weeks, twice daily for 14 consecutive days to the patients who have completed 6 cycles in the study 2012002…
- Trial name
- NCT02002936
- Testing
- SyB C-1101
- Where
- 4 sites in Japan
- Volunteers
- 1 people
- Sponsor
- SymBio Pharmaceuticals
Bipolar Disorder
A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.
This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed.
- Trial name
- NCT00282464
- Testing
- Geodon (Ziprasidone)
- Where
- 43 sites in United States
- Volunteers
- 392 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Age Related Macular Degeneration, Choroidal Neovascularization
SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A.
- Trial name
- NCT00331864
- Testing
- Ranibizumab
- Where
- Switzerland
- Volunteers
- 531 people
- Sponsor
- Novartis
Congestive Heart Failure
Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar
The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead.
- Trial name
- CELESTIAL (NCT00810264)
- Testing
- CRT Therapy - LV Lead Registry
- Where
- 86 sites in United States
- Volunteers
- 2,499 people
- Sponsor
- Biotronik, Inc.
Major Depressive Disorder
Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)
- Trial name
- NCT01323478
- Testing
- Vortioxetine (Lu AA21004)
- Volunteers
- 71 people
- Sponsor
- H. Lundbeck A/S
Pulmonary Disease, Chronic Obstructive
BI 113608 Administered as Tablets Twice Daily Over 4 Weeks in Patients With Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis
The main objective of the current trial is to investigate safety, tolerability and pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis.
- Trial name
- NCT01958008
- Testing
- BI 113608 high dose b.i.d., BI 113608 low dose b.i.d.
- Where
- 6 sites in Germany
- Volunteers
- 84 people
- Sponsor
- Boehringer Ingelheim
Seasonal Allergic Rhinitis
A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies
The purpose of this study was to determine if two allergy medications are more effective than placebo.
- Trial name
- NCT00720278
- Testing
- 0.15% azelastine hydrochloride 1644 mcg daily, 0.1% azelastine hydrochloride 1096 mcg daily
- Where
- 29 sites in United States
- Volunteers
- 526 people
- Sponsor
- Meda Pharmaceuticals
Atopic Dermatitis
Combination Therapy for Atopic Dermatitis
Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications.
- Trial name
- NCT00119158
- Testing
- Combination of pimecrolimus and fluticasone, pimecrolimus
- Where
- 3 sites in United States
- Volunteers
- 90 people
- Sponsor
- Children's Hospital of Philadelphia
Chronic Obstructive Pulmonary Disease (COPD)
Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.
- Trial name
- NCT00570778
- Testing
- indacaterol/glycopyrrolate, indacaterol
- Where
- 22 sites in United States, Belgium and 3 more
- Volunteers
- 154 people
- Sponsor
- Novartis Pharmaceuticals
Onychomycosis of Toenails
Evaluation Study for the Efficacy and Safety of PinPointe FootLaser in Treatment for Onychomycosis
The purpose of this study is to assess the clinical efficacy and safety of the PinPointe Foot Laser device for the treatment of patients with onychomycosis who have been previously treated with oral Terbinafine and failed.
- Trial name
- NCT01920178
- Testing
- PinPointe Foot Laser
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Cambridge Health Alliance
Diabetes Mellitus, Type 2
Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only
This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only.
- Trial name
- NCT00518115
- Testing
- Albiglutide (GSK716155) or exenatide
- Where
- 163 sites in United States, Chile and 1 more
- Volunteers
- 361 people
- Sponsor
- GlaxoSmithKline
Becker Muscular Dystrophy
Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy
Objectives: Primary objective: to establish the histological effects of Givinostat versus placebo administered over 12 months. Secondary Objectives: To establish the macroscopic muscle effects of Givinostat versus placebo…
- Trial name
- NCT03238235
- Testing
- Givinostat
- Where
- 2 sites in Italy, Netherlands
- Volunteers
- 51 people
- Sponsor
- Italfarmaco
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