Clinical trials: Estrogen Receptor Negative
Breast Cancer
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre…
- Trial name
- AMALEE (NCT03822468)
- Testing
- Ribociclib, Anastrozole, Letrozole
- Where
- 89 sites in United States, Argentina and 21 more
- Volunteers
- 376 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Food Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg
The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administered…
- Trial name
- NCT00648076
- Testing
- Divalproex Sodium Extended-Release Tablets 500 mg, Depakote ER® Tablets 500 mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Advanced Solid Tumors, Metastatic Triple Negative Breast Cancer
Study of NK012 and Carboplatin in Solid Tumors With Dose Expansion in Triple Negative Breast Cancer
The primary objective is to determine the maximum tolerated dose/recommended phase II dose of the combination regimen of NK012 and carboplatin in patients with advanced solid tumors.
- Trial name
- NCT01238952
- Testing
- NK012 and carboplatin
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Nippon Kayaku Co., Ltd.
Advanced or Metastatic Breast Cancer, ER+ve Advanced or Metastatic Breast Cancer
Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients
The purpose of this study is to investigate the safety and efficacy of different doses and schedules of AZD5363, when in combination with paclitaxel, in treatment of patients with advanced or metastatic breast cancer.
- Trial name
- BEECH (NCT01625286)
- Testing
- AZD5363 when combined with weekly paclitaxel., AZD5363when combined with weekly paclitaxel.
- Where
- 41 sites in Bulgaria, Canada and 9 more
- Volunteers
- 148 people
- Sponsor
- AstraZeneca
Healthy
Study to Evaluate Different Extended Release (ER)-Formulations and Multiple Ascending Dosing of AZD3241
The aims of the study are to assess the safety, tolerability and pharmacokinetics of ER tablets of AZD3241 following multiple ascending doses administered to healthy male and female subjects including the effect of food.
- Trial name
- NCT00914303
- Testing
- AZD3241
- Where
- Sweden
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Idiopathic Pulmonary Fibrosis
NAL ER IPF Respiratory Function and Safety Study
The primary purpose of this study is to assess the safety and tolerability of escalating doses of NAL ER and to evaluate its effect on respiratory function in participants with IPF.
- Trial name
- NCT07036029
- Testing
- NAL ER
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 9 people
- Sponsor
- Trevi Therapeutics
Healthy
Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR in Healthy Subjects
The purpose of this study is to determine if the relative difference in PK between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.
- Trial name
- NCT00329186
- Testing
- desvenlafaxine SR, venlafaxine ER
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
Bioequivalence of a New Asasantin Formulation Extended Release (ER) Compared to the Commercially Available Asasantin Formulation (Aggrenox®; Extended Release) in Healthy Male and Female Volunteers
Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the present commercially available Asasantin ER formulation (Aggrenox®)
- Trial name
- NCT02273531
- Testing
- Asasantin ER, new formulation, Asasantin ER, present commercial formulation
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Schizophrenia, Schizophrenic Disorders
Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.
The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.
- Conditions
- Schizophrenia, Schizophrenic Disorders, Psychotic Disorders, Dementia Praecox
- Trial name
- NCT00488319
- Testing
- Paliperidone ER
- Where
- 53 sites in United States, Belgium and 9 more
- Volunteers
- 400 people
- Sponsor
- Janssen Research & Development, LLC
Chronic Pain
A Study to Assess the Improvement of Pain and Health-Related Quality of Life in Patients With Chronic Non-Malignant Pain Taking Tramadol Hydrochloride and Acetaminophen
The purpose of this study is to evaluate the impact of extended release tramadol hydrochloride (75 mg) and acetaminophen (650 mg) tablets on improvement of pain.
- Trial name
- NCT01819805
- Testing
- No intervention
- Where
- 14 sites in South Korea
- Volunteers
- 1,065 people
- Sponsor
- Janssen Korea, Ltd., Korea
Schizophrenia, Insomnia
Trial Evaluating Paliperidone Extended-Release (ER) Tablets Versus Placebo on Sleep in Schizophrenia Patients
The primary objective of this study is to evaluate the amelioration of the sleep architecture of patients with schizophrenia and schizophrenia-related insomnia, treated with either 9 mg of extended-release paliperidone ER or…
- Trial name
- NCT00105326
- Testing
- paliperidone ER
- Volunteers
- 5 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Cancer, Breast Cancer
A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
- Conditions
- Cancer, Breast Cancer, Endometrial Cancer, Metastatic Cancer
- Trial name
- NCT06533059
- Testing
- ALTA2618
- Where
- 31 sites in United States, Australia and 6 more
- Volunteers
- 110 people
- Sponsor
- Alterome Therapeutics, Inc.
Hot Flashes
Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women.
Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women
- Trial name
- NCT00777023
- Testing
- Gabapentin Extended-Release (G-ER) 1200 mg, Gabapentin Extended-Release (G-ER) 1800 mg
- Where
- 45 sites in United States
- Volunteers
- 565 people
- Sponsor
- Depomed
Breast Neoplasms, Invasive Breast Cancer
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer.
- Conditions
- Breast Neoplasms, Invasive Breast Cancer, Estrogen-receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- EVANGELINE (NCT05607004)
- Testing
- (Z)-endoxifen, goserelin
- Where
- 14 sites in United States
- Volunteers
- 87 people
- Sponsor
- Atossa Therapeutics, Inc.
Healthy
Fasting Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under…
- Trial name
- NCT00649129
- Testing
- Oxybutynin Chloride ER Tablets 10 mg, Ditropan XL® Tablets 10 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Urinary Bladder, Overactive
A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency.
- Trial name
- NCT01302054
- Testing
- Fesoterodine 8 mg
- Where
- 176 sites in United States, Bulgaria and 13 more
- Volunteers
- 990 people
- Sponsor
- Pfizer
Opioid Related Disorders, Opiate Addiction
Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics
Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could…
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02920775
- Testing
- Non-interventional study - retrospective database review
- Volunteers
- 360,000 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Pain
A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone Controlled Release (CR)) in Japanese and Korean…
- Trial name
- NCT01165281
- Testing
- Oxycodone CR, R331333 (referred to as JNS024 ER or CG5503)
- Where
- 52 sites in Japan, South Korea
- Volunteers
- 343 people
- Sponsor
- Janssen Research & Development, LLC
Pain
Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain
The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain.
- Trial name
- NCT00913627
- Testing
- ibuprofen, naproxen
- Where
- United States
- Volunteers
- 196 people
- Sponsor
- Pfizer
Congestive Heart Failure, Chronic Kidney Diseases
Within Subject Variability Study of ER Torsemide 20 mg Tablet in Healthy Subjects
The study will evaluate the within-subject variability of 20mg ER torsemide as compared to 20mg IR torsemide (Demadex) in fully replicate double-crossover trial in healthy volunteers, who are consuming a high-salt diet (300…
- Trial name
- NCT03214874
- Testing
- Demadex 20mg Tablet, ER Torsemide 20mg Tablet
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sarfez Pharmaceuticals, Inc.