AMERICAN REGENT, INC.

🇺🇸United States

Country: 🇺🇸United States

Ownership: Subsidiary

Established: 1967-01-01

Employees: 501

Market Cap: -

Website: http://www.americanregent.com

Clinical Trials

Safety, Tolerability, and Pharmacokinetic Study of Methylene Blue Following a 1 mg/kg Intravenous Dose in Healthy Adults

Phase 1

Completed

Conditions: Methemoglobinemia
Congenital Methemoglobinemia

Interventions: Drug: Methylene Blue

First Posted Date: 2015-06-23

Last Posted Date: 2018-01-25

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 12

Registration Number: NCT02478281

Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®

Phase 3

Completed

Conditions: Cancer and Chemotherapy Related Anemia

Interventions: Other: Normal Saline
Drug: Injectafer

First Posted Date: 2015-05-25

Last Posted Date: 2021-05-11

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 244

Registration Number: NCT02453334

Locations: 🇺🇸
Lakes Research, Miami Lakes, Florida, United States
🇺🇸
Michiana Hematology Oncology, PC, South Bend, Indiana, United States
🇺🇸
Compassionate Care Research Group, Inc., Riverside, California, United States

and more 24 locations

A Study to Characterize the PK and PD Profile of IV FCM in Pediatric Subjects 1-17 Years Old With IDA

Phase 2

Completed

Conditions: Iron Deficiency Anemia (IDA)

Interventions: Drug: Ferric Carboxymaltose (FCM)

First Posted Date: 2015-04-07

Last Posted Date: 2022-07-25

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 35

Registration Number: NCT02410213

Locations: 🇵🇱
Indywidualna Specjalistyczna Praktyka lekarska z siedzibą w Rzeszowie, Rzeszów, Poland
🇵🇱
Uniwersytecki Szpital Dziecięcy w Krakowie, Oddział Pediatrii i Gastroenterologii (V), Kraków, Poland
🇷🇺
State Budgetary Educational Institution of Higher Professional Education "Ryazan State Medical University named after academician I.P. Pavlov" of the Ministry of Health of the Russian Federation, Ryazan', Russian Federation

and more 7 locations

Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia

Phase 2

Completed

Conditions: Iron Deficiency
Fibromyalgia

Interventions: Drug: Placebo
Drug: Injectafer

First Posted Date: 2015-04-06

Last Posted Date: 2018-02-20

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 81

Registration Number: NCT02409459

Locations: 🇺🇸
Clinical Research Solutions, Franklin, Tennessee, United States

Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS

Phase 3

Completed

Conditions: Restless Legs Syndrome (RLS)

Interventions: Other: Placebo
Drug: Injectafer

First Posted Date: 2015-03-24

Last Posted Date: 2021-10-12

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 209

Registration Number: NCT02397057

Locations: 🇺🇸
Egret Bay Neurology, Houston, Texas, United States
🇺🇸
Elite Research Institute, Miami, Florida, United States
🇺🇸
The Polyclinic, Madison Center, Seattle, Washington, United States

and more 16 locations

Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass

Phase 4

Completed

Conditions: Iron Deficiency Anemia Secondary to IBD or Gastric Bypass

Interventions: Drug: Ferrous Sulfate tablets
Drug: Injectafer

First Posted Date: 2014-03-13

Last Posted Date: 2020-09-17

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 198

Registration Number: NCT02086968

Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia

Completed

Conditions: Iron Deficiency Anemia (IDA)

First Posted Date: 2013-11-14

Last Posted Date: 2018-01-24

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 551

Registration Number: NCT01984554

Locations: 🇺🇸
Luitpold Pharmaceuticals, Inc., Norristown, Pennsylvania, United States

Trial to Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and to Compare Safety, Effect on Quality of Life, and Resource Utilization of Injectafer vs Intravenous Standard of Care for the Treatment of IDA in an Infusion Center Setting

Phase 4

Conditions: Iron Deficiency Anemia (IDA)

Interventions: Drug: SOC
Drug: Injectafer

First Posted Date: 2013-09-25

Last Posted Date: 2017-09-08

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 1000

Registration Number: NCT01950247

Pharmacokinetics, Safety, and Efficacy of SPRIX in 12 to 17 Year Old Patients vs. Adult Patients Undergoing Open Surgical Procedures

Phase 3

Completed

Conditions: Pain

Interventions: Drug: SPRIX

First Posted Date: 2013-03-27

Last Posted Date: 2015-07-07

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 60

Registration Number: NCT01819610

Locations: 🇺🇸
Luitpold Pharmaceuticals, Inc., Norristown, Pennsylvania, United States

Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)

Phase 2

Completed

Conditions: Restless Legs Syndrome (RLS)

Interventions: Drug: Ferric Carboxymaltose (FCM)
Drug: Placebo

First Posted Date: 2011-06-27

Last Posted Date: 2018-02-20

Lead Sponsor: American Regent, Inc.

Target Recruit Count: 45

Registration Number: NCT01382901

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