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NCT ID: NCT01866111 Completed - Partial Epilepsy Clinical Trials

A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Start date: July 31, 2013
Phase: Phase 2
Study type: Interventional

This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for subjects who will participate in the open-label extension). The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures. The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.

NCT ID: NCT01865747 Completed - Clinical trials for Renal Cell Carcinoma

A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma

METEOR
Start date: June 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.

NCT ID: NCT01865253 Terminated - Hypertension Clinical Trials

Renal Denervation for Complicated Hypertension

RDNP-2012-03
Start date: May 2012
Phase: Phase 4
Study type: Interventional

This is an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to: - intolerance to antihypertensive medication - inability to take antihypertensive medication due to planned pregnancy - renal artery stenosis - chronic kidney disease - non-compliance to antihypertensive medication A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study. The duration of this study is 36 months.

NCT ID: NCT01865240 Terminated - Hypertension Clinical Trials

Renal Denervation for Resistant Hypertension

RDNP-2012-01
Start date: February 2012
Phase: Phase 4
Study type: Interventional

This is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.

NCT ID: NCT01864798 Terminated - Breast Neoplasms Clinical Trials

A Study to Evaluate Denosumab in Young Patients With Primary Breast Cancer

D-Beyond
Start date: July 2013
Phase: Phase 2
Study type: Interventional

This is a prospective, single arm phase IIa trial in which patients with early breast cancer will receive pre-operatively two doses of denosumab 120mg subcutaneously one week apart (maximum 12 days) followed by surgery. Tumor, normal breast tissue and blood samples will be collected at baseline and at surgery. Post-operative treatment will be at the discretion of the investigator. Primary objective: to determine if a short course of RANKL inhibition with denosumab can induce a decrease in tumor proliferation rates as determined by Ki67 immunohistochemistry (IHC) in newly diagnosed, early stage breast cancer in pre-menopausal women. Secondary objectives: - To determine the number of absolute Ki67 responders after a short course of denosumab (defined as <2.7% IHC staining in the post treatment tumor biopsy). - To determine the effects of a short course of denosumab on serum C-terminal telopeptide levels (CTX). - To determine the effects of a short course of denosumab on RANK/RANKL gene expression and signaling as assessed by immunohistochemistry (IHC) and RNA sequencing in the tumor. - To determine the effect of a short course of denosumab on tumor apoptosis rates using IHC - To determine the effect of a short course of denosumab on modulating the immature mammary epithelial cell populations in the tumor. - To determine the effect of a short course of denosumab on estrogen signaling pathways in the tumor. - To determine the effect of a short course of denosumab on various immune - To determine effect of safety profile of denosumab

NCT ID: NCT01864746 Completed - Breast Cancer Clinical Trials

A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

PENELOPE-B
Start date: October 30, 2013
Phase: Phase 3
Study type: Interventional

The PENELOPEB study is designed to demonstrate that, in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.

NCT ID: NCT01863225 Terminated - Clinical trials for Coronary Artery Disease

Characterization of Multi-dose RVX000222 in Combination With Statin Treatment in Dyslipidemia

Start date: May 2013
Phase: Phase 2
Study type: Interventional

This study is designed to characterize the pharmacokinetics of multi-dose RVX000222 and atorvastatin and rosuvastatin when either statin is administered in combination with RVX000222 in subjects with dyslipidemia.

NCT ID: NCT01861002 Completed - Clinical trials for Lymphoblastic Leukemia, Acute, Childhood

A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML

Start date: May 22, 2013
Phase: Phase 1
Study type: Interventional

This is a Phase I study with a conditional cohort expansion phase to evaluate the feasibility of, and to obtain preliminary efficacy data about, pretreatment with Azacytidine (AZA) for 5 days followed by fludarabine/cytarabine chemotherapy regimen in pediatric acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) patients who are refractory to primary treatment or who relapsed.

NCT ID: NCT01858961 Withdrawn - Clinical trials for Hepatitis C, Chronic

Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients

Start date: May 2013
Phase: Phase 3
Study type: Interventional

The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients, including patients with compensated cirrhosis.

NCT ID: NCT01857206 Completed - Influenza Clinical Trials

Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

Start date: May 2013
Phase: Phase 3
Study type: Interventional

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.