Clinical trials: Stage III
Chemotherapy Associated Neutropenia, Breast Cancer
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
- Trial name
- PIONEER (NCT01519700)
- Testing
- EP2006, Filgrastim
- Where
- 26 sites in Czechia, Hungary and 4 more
- Volunteers
- 218 people
- Sponsor
- Sandoz
Reproductive Techniques, Assisted
Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle
The present study was designed to investigate, in hyporesponder subjects, that required in a previous assisted reproductive technologies (ART) cycle follicle stimulating hormone (FSH) >3500 International Unit (IU), the…
- Trial name
- Luveris in ART (NCT01071200)
- Testing
- Recombinant human Follicle Stimulating Hormone (r-hFSH) and Recombinant human Luteinizing Hormone (r-hLH), r-hFSH
- Where
- Italy
- Volunteers
- 133 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Influenza
Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Different Suppliers
The purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V using two different HA antigen suppliers (AdImmune…
- Trial name
- NCT01412281
- Testing
- Virosomal influenza vaccine (AdImmune HA Antigen), Virosomal influenza vaccine (CSL HA Antigen)
- Where
- Switzerland
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Post-Menopausal Osteoporosis
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva
This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study).
- Trial name
- NCT00081653
- Testing
- ibandronate [Bonviva/Boniva]
- Where
- 31 sites in United States, Belgium and 12 more
- Volunteers
- 719 people
- Sponsor
- Hoffmann-La Roche
Chronic Obstructive Pulmonary Disease
Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients
This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one inhalation b.i.d, or standard COPD therapy.
- Trial name
- NCT01047553
- Testing
- Formoterol (OT)
- Where
- 27 sites in Japan
- Volunteers
- 251 people
- Sponsor
- AstraZeneca
Adenomatous Polyposis Coli
Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)
To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).
- Trial name
- CHIP (NCT00585312)
- Testing
- Celecoxib
- Where
- 42 sites in United States, Belgium and 12 more
- Volunteers
- 106 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Brain Edema, Brain Tumor
XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema).
- Trial name
- NCT00088166
- Testing
- hCRF
- Where
- 34 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Celtic Pharma Development Services
Asthma, Exercise-Induced
A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma
The purpose of this Phase III, multicentre, randomized, double-blind, single-dose, 2-period, crossover study is to assess the efficacy and safety of PT027 (budesonide/albuterol sulfate) metered-dose inhaler compared with placebo…
- Trial name
- BREATH (NCT06245551)
- Testing
- Budesonide/albuterol metered-dose inhaler 160/180 μg
- Where
- 6 sites in Russia
- Volunteers
- 64 people
- Sponsor
- AstraZeneca
Geographic Atrophy
A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy…
- Trial name
- SPECTRI (NCT02247531)
- Testing
- Lampalizumab
- Where
- 153 sites in United States, Argentina and 20 more
- Volunteers
- 975 people
- Sponsor
- Hoffmann-La Roche
Asthma
Evaluation of Tiotropium 2.5 and 5 µg Once Daily Delivered Via the Respimat Inhaler Compared to Placebo in Patient With Moderate to Severe Persistent Asthma
The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over a 52-week treatment period as compared to placebo.
- Trial name
- NCT01340209
- Testing
- Tiotropium Respimat
- Where
- 55 sites in Japan
- Volunteers
- 285 people
- Sponsor
- Boehringer Ingelheim
Uveitis; Posterior, Disorder
Study Assessing Double-masked Uveitis Treatment
The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.
- Trial name
- SAKURA (NCT01358266)
- Testing
- DE-109 44 ug, DE-109 440 ug, DE-109 880 ug
- Where
- 151 sites in United States, Argentina and 15 more
- Volunteers
- 592 people
- Sponsor
- Santen Inc.
Non-small Cell Lung Cancer
Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Participants With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy
The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival time without disease progression in the…
- Trial name
- NCT00533429
- Testing
- enzastaurin, pemetrexed, carboplatin
- Where
- 12 sites in United States
- Volunteers
- 40 people
- Sponsor
- Eli Lilly and Company
Rheumatoid Arthritis
A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis
An open ended study in which patients who completed the double-blind study CDP870-027 [NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).
- Trial name
- NCT00175877
- Testing
- Certolizumab Pegol
- Where
- 121 sites in United States, Argentina and 20 more
- Volunteers
- 857 people
- Sponsor
- UCB Pharma
Chronic Obstructive Pulmonary Disease
Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in…
- Trial name
- NCT01572792
- Testing
- Aclidinium bromide/formoterol Fixed-Dose Combination (FDC), Aclidinium bromide, Formoterol Fumarate
- Where
- 208 sites in United States, Australia and 2 more
- Volunteers
- 921 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)
This is a Phase III, multicenter, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy compared with chemotherapy alone in subjects with previously…
- Trial name
- NCT00262067
- Testing
- Bevacizumab, Chemotherapy
- Where
- 92 sites in United States, Australia and 20 more
- Volunteers
- 1,237 people
- Sponsor
- Genentech, Inc.
Neoplasms, Breast
A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).
- Trial name
- NCT01160211
- Testing
- Lapatinib, Trastuzumab, Aromatase Inhibitor
- Where
- 110 sites in United States, Argentina and 27 more
- Volunteers
- 369 people
- Sponsor
- Novartis Pharmaceuticals
Myeloid Leukemia, Chronic, Chronic-Phase
Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).
- Trial name
- NCT00123474
- Testing
- dasatinib
- Where
- 137 sites in United States, Argentina and 29 more
- Volunteers
- 724 people
- Sponsor
- Bristol-Myers Squibb
Urinary Tract Infection (UTI), Complicated Urinary Tract Infection
Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014)
This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) for the treatment of complicated urinary tract infection (cUTI) including…
- Conditions
- Urinary Tract Infection (UTI), Complicated Urinary Tract Infection, Pyelonephritis, Uncomplicated Pyelonephritis
- Trial name
- NCT02728089
- Testing
- MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g)
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus
Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)
This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV)…
- Trial name
- C-SURFER (NCT02092350)
- Testing
- Grazoprevir, Elbasvir
- Volunteers
- 237 people
- Sponsor
- Merck Sharp & Dohme LLC
Surgical Site Infection, Colon Surgery
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), compared to a SoC treated…
- Conditions
- Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
- Trial name
- NCT04233424
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 62 sites in United States, Bulgaria and 8 more
- Volunteers
- 977 people
- Sponsor
- PolyPid Ltd.
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