Clinical Trials Logo

Filter by:
NCT ID: NCT01485172 Completed - Parkinson Disease Clinical Trials

A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease

TANDEM-662
Start date: January 31, 2012
Phase: Phase 4
Study type: Interventional

This study is a fixed dose, dose response study to characterize the dose response for ropinirole PR in early stage PD patients (Hoehn & Yahr stages I-III). After screening and baseline assessments, subjects will be randomized to one of six final target treatment groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening period, an up-titration period, a maintenance period, a down titration period and a follow up period. This study utilizes change from baseline in the UPDRS motor score as the primary endpoint, in line with that used in the ropinirole PR monotherapy pivotal study (SK&F101468/168). Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.

NCT ID: NCT01483742 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis

Start date: April 2012
Phase: Phase 2
Study type: Interventional

This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.

NCT ID: NCT01482962 Completed - Clinical trials for Relapsed Peripheral T-Cell Lymphoma

Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

Start date: June 11, 2012
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available.

NCT ID: NCT01482221 Completed - Clinical trials for Major Depressive Disorder

A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder

Start date: December 16, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the effect and safety of AZD6765 in patients with major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a channel blocker of the N-methyl-D-aspartate (NMDA) class of glutamate receptors.

NCT ID: NCT01476475 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

Start date: November 2011
Phase: Phase 2
Study type: Interventional

Primary Objective: - The purpose of this study is to compare insulin glargine/ lixisenatide fixed ratio combination versus insulin glargine on glycemic control over 24 weeks, as evaluated by HbA1c (glycosylated hemoglobin) reduction in type 2 diabetic patients treated with metformin Secondary Objectives: - To compare insulin glargine/lixisenatide fixed ratio combination versus insulin glargine over 24 weeks on: - Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test - Percentage of patients reaching HbA1c <7% or ≤6.5% - 7-point Self-Monitored Plasma Glucose (SMPG) profile - Body weight - Insulin glargine dose - Fasting Plasma Glucose (FPG) - Percentage of patients requiring rescue therapy during the 24-week open label treatment period - To assess safety and tolerability of insulin glargine/ lixisenatide fixed ratio combination.

NCT ID: NCT01475721 Completed - Asthma Clinical Trials

SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.

AUSTRI
Start date: November 18, 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone. ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.

NCT ID: NCT01475461 Completed - Clinical trials for Type 2 Diabetes Mellitus

Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes

Start date: November 2011
Phase: Phase 2
Study type: Interventional

B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes

NCT ID: NCT01475032 Completed - Asthma Clinical Trials

Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children

PAED2/FRESH
Start date: September 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose inhaler (pMDI) is non-inferior to the corresponding dose of free combination of Beclomethasone (BDP) and Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung functions in asthmatic children patients.

NCT ID: NCT01472185 Completed - Clinical trials for Type 2 Diabetes Mellitus

Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

Start date: November 2011
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to determine the effect of ranolazine when given as monotherapy on glycemic control in subjects with type 2 diabetes mellitus (T2DM) who were inadequately controlled with diet and exercise alone and who are treatment naive to antihyperglycemic therapy or have not received antihyperglycemic therapy in the 90 days (or thiazolidinediones [TZDs] for at least 24 weeks) prior to screening, and to characterize the relationship between HbA1c reduction and other glycemic parameters in subjects with T2DM.

NCT ID: NCT01470612 Completed - Ulcerative Colitis Clinical Trials

Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis

OCTAVE
Start date: October 1, 2012
Phase: Phase 3
Study type: Interventional

This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.