Clinical trials: Estrogen Receptor Negative
- Condition Estrogen Receptor Negative
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Healthy
Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers
Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.
- Trial name
- NCT01119443
- Testing
- PPX ER
- Where
- Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Early Breast Cancer
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus…
- Trial name
- NCT04436744
- Testing
- Giredestrant, Anastrozole, Palbociclib
- Where
- 65 sites in United States, Australia and 9 more
- Volunteers
- 221 people
- Sponsor
- Hoffmann-La Roche
Parkinson's Disease
Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study
The study had three distinct parts and is described as follows: Part 1: To evaluate the dose conversion from CD-LD ER taken alone or in combination with CD-LD IR to IPX066 in subjects with advanced PD To evaluate the utility of…
- Trial name
- NCT01411137
- Testing
- IPX066
- Where
- 8 sites in United States
- Volunteers
- 43 people
- Sponsor
- Impax Laboratories, LLC
Diabetes Mellitus Type 2
Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069)
A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant versus placebo in Type 2 Diabetes Mellitus patients.
- Trial name
- NCT00485758
- Testing
- ER niacin/laropiprant
- Volunteers
- 796 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment…
- Trial name
- COMPLEEMENT-1 (NCT02941926)
- Testing
- Ribociclib, Letrozole, Goserelin
- Where
- 495 sites in United States, Argentina and 36 more
- Volunteers
- 3,246 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Pain
Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients
This pediatric study is designed to provide safety information, dosing guidelines, and a pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl) extended-release (ER) tablets in children with chronic…
- Trial name
- NCT02321319
- Testing
- Hydromorphone HCl ER Tablets
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Mallinckrodt
Breast Neoplasms
Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or…
- Trial name
- NCT00073528
- Testing
- Lapatinib, Letrozole
- Where
- 278 sites in United States, Argentina and 27 more
- Volunteers
- 1,286 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at…
- Trial name
- EMERALD (NCT03778931)
- Testing
- Elacestrant, Standard of Care
- Where
- 244 sites in United States, Argentina and 15 more
- Volunteers
- 478 people
- Sponsor
- Stemline Therapeutics, Inc.
Schizophrenia
A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia
The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia.
- Trial name
- NCT00396565
- Testing
- ER OROS paliperidone, Olanzapine
- Where
- 56 sites in Japan
- Volunteers
- 394 people
- Sponsor
- Janssen Pharmaceutical K.K.
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.
- Trial name
- NCT00479388
- Testing
- Comparator: simvastatin, niacin (+) laropiprant, Comparator: atorvastatin calcium
- Volunteers
- 1,216 people
- Sponsor
- Merck Sharp & Dohme LLC
FGFR Inhibition, Pharmacokinetics, Biomarkers, ER+ Breast Cancer
Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients
The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)
- Trial name
- GLOW (NCT01202591)
- Testing
- AZD4547, Exemestane, Fulvestrant
- Where
- 21 sites in Belgium, Czechia and 6 more
- Volunteers
- 127 people
- Sponsor
- AstraZeneca
Dyslipidemia
Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR
A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to K-877 immediate release (IR) twice daily (BID).
- Trial name
- NCT04447820
- Testing
- K-877-ER (Dose A), K-877-ER (Dose B), K-877-IR
- Where
- 12 sites in United States
- Volunteers
- 96 people
- Sponsor
- Kowa Research Institute, Inc.
Hypercholesterolemia
A Study to Evaluate the Effects of Extended Release (ER) Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With High Cholesterol (0524A-075)(COMPLETED)
The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a metabolite of thromboxane A2 (TxA2), as a marker of…
- Trial name
- NCT00769132
- Testing
- Comparator: niacin + laropiprant, Comparator: niacin, Comparator: laropiprant
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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 (G-ER) is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.
- Trial name
- NCT00755417
- Testing
- Gabapentin Extended-Release (G-ER) 1200 mg, Gabapentin Extended-Release (G-ER) 1800 mg
- Where
- 45 sites in United States
- Volunteers
- 541 people
- Sponsor
- Depomed
Dementia
The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life
The purpose of this study is to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life.
- Trial name
- NCT00814658
- Testing
- Galantamine, Nimodipine
- Volunteers
- 22 people
- Sponsor
- Janssen-Cilag Farmaceutica Ltda.
Diabetes, Diabetes Mellitus, Type 2
Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes
This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2…
- Trial name
- SUSTAIN™ 3 (NCT01885208)
- Testing
- semaglutide, exenatide
- Where
- 146 sites in United States, Argentina and 11 more
- Volunteers
- 813 people
- Sponsor
- Novo Nordisk A/S
Breast Neoplasms, Neoplasm Metastasis
A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is…
- Trial name
- EMBER-3 (NCT04975308)
- Testing
- Imlunestrant, Exemestane, Fulvestrant
- Where
- 243 sites in United States, Argentina and 20 more
- Volunteers
- 874 people
- Sponsor
- Eli Lilly and Company
Major Depressive Disorder
Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and venlafaxine ER 75 mg/day to 225 mg/day (flexible…
- Trial name
- NCT01441440
- Testing
- venlafaxine ER 75 mg/day (fixed dose), venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)
- Where
- 63 sites in Japan
- Volunteers
- 538 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)
The purpose of this study is to compare the subjective and objective effects of Oxymorphone ER (Opana ER) versus Oxycodone CR (Oxycontin).
- Trial name
- NCT00955110
- Testing
- Oxymorphone ER, Oxycodone CR, Hydromorphone
- Where
- Canada
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Pharmacokinetics
Drug-Drug Interaction Between Colchicine and Verapamil ER
Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp). Verapamil hydrochloride is a potent inhibitor of cytochrome P450 (CYP) 3A4 and P-gp.
- Trial name
- NCT00983242
- Testing
- Colchicine, Verapamil HCl ER
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.