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NCT ID: NCT01970618 Completed - Healthy Volunteers Clinical Trials

Safety, Tolerability and Pharmacokinetics (PK) of RV1162 in Healthy Subjects and COPD Patients

Start date: October 2013
Phase: Phase 1
Study type: Interventional

RV1162 is a new medicine being developed for possible treatment of smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single and repeat doses of RV1162.

NCT ID: NCT01970553 Completed - Clinical trials for Specific Advanced Solid Tumors

Escalating Doses of PM01183 in Combination With Gemcitabine in Patients With Specific Unresectable Solid Tumors

Start date: May 2011
Phase: Phase 1
Study type: Interventional

Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in combination with gemcitabine in non-heavily pretreated patients with selected advanced solid tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with gemcitabine, to characterize the safety profile and feasibility of this combination in patients with selected advanced solid tumors, to characterize the pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity in non-heavily pretreated selected solid tumor patients and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed, in order to assess potential markers of response and/or resistance.

NCT ID: NCT01970540 Completed - Clinical trials for Neuroendocrine Tumors

Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors

Start date: May 25, 2011
Phase: Phase 1
Study type: Interventional

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination with Fixed Doxorubicin in Non- Heavily Pretreated Patients with Selected Advanced Solid Tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with doxorubicin, to characterize the safety profile and feasibility of this combination, to characterize the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity,to explore the feasibility, safety and efficacy of a potential improvable dose of this combination in selected tumor types [i.e. small cell lung cancer (SCLC) and endometrial cáncer] and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed to PM01183 and doxorubicin at the RD in order to assess potential markers of response and/or resistance.

NCT ID: NCT01970475 Completed - Clinical trials for Arthritis, Rheumatoid

Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

RA
Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness and safety of ABP 501 against Adalimumab (Humira®) in adult subjects with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).

NCT ID: NCT01970319 Completed - Type 2 Diabetes Clinical Trials

Mechanisms and Reversibility of Heart Failure Associated With Diabetes

MRHD
Start date: October 2013
Phase: N/A
Study type: Observational

Patients with diabetes have a higher incidence of heart failure and worse outcomes than normoglycaemic subjects. Basic science research has suggested many mechanisms for this observation including endothelial dysfunction, abnormal calcium handling, fibrosis and activation of the renin-angiotensin-aldosterone system (RAAS), but clinical data are lacking. In this study the investigators will investigate the relationship between diabetes and heart failure by exploring the correlation between microvascular dysfunction and cardiac magnetic resonance (CMR) markers of left ventricular (LV) hypertrophy, cardiac dysfunction and fibrosis. The investigators also propose to see if this relationship is independent of blood pressure and markers of RAAS activity. This could have important clinical ramifications in type 2 diabetes by increasing the indications for treatment with RAAS inhibition or making a case for lower blood pressure targets.

NCT ID: NCT01969838 Completed - Clinical trials for Primary Myelofibrosis

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

Simplify 1
Start date: December 6, 2013
Phase: Phase 3
Study type: Interventional

This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor). Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.

NCT ID: NCT01969734 Completed - Moderate COPD Clinical Trials

Endobronchial Valves in Moderate COPD

REMODEL
Start date: March 2014
Phase: N/A
Study type: Interventional

Despite the best medical therapy many people with emphysema remain breathless and limited in their daily activities. In emphysema the lungs do not empty properly when the person breathes out. This "gas trapping" makes it harder to breathe. Endobronchial valve placement, a treatment that stops air getting into the worst affected parts of the lung and so stops them from trapping gas, improves lung function, breathlessness and exercise capacity in selected patients with severe COPD (chronic obstructive airways disease, sometimes referred to as emphysema). We want to see if people with less severe COPD who are very breathless can benefit from the same treatment. The treatment involves placing small valves into the airways using a fibre optic camera (a bronchoscopy). Bronchoscopy is a standard clinical procedure carried out in our department.

NCT ID: NCT01969617 Completed - Alcohol Dependence Clinical Trials

Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) fMRI Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge

Start date: November 2013
Phase: Phase 1
Study type: Interventional

To contribute to the understanding of the underlying neurobiological mechanism behind the interaction of alcohol and nalmefene

NCT ID: NCT01969201 Completed - Infertility Clinical Trials

FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)

FAST
Start date: January 2014
Phase: Phase 4
Study type: Interventional

The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.

NCT ID: NCT01968980 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia

SPIRE-FH
Start date: October 2013
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.