Clinical Trials Logo

Filter by:
NCT ID: NCT00430729 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)

Start date: January 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life in patients with chronic obstructive pulmonary disease (COPD).

NCT ID: NCT00428090 Completed - Alzheimer's Disease Clinical Trials

Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease

Start date: February 2007
Phase: Phase 3
Study type: Interventional

Rosiglitazone (RSG) has been tested and is approved as a treatment for type II diabetes mellitus, a disease that occurs when the body ineffectively uses glucose. RSG XR, the investigational drug, is an extended-release form of RSG. This study tests whether RSG XR safely provides benefit to people with mild to moderate Alzheimer's disease (AD). RSG XR is a new approach to AD therapy and this study tests whether one's genes alter the effectiveness of RSG XR. Glucose is used by cells to make energy that they need to live. Changes in the ability of cells to use of glucose can lead to diseases like diabetes. Glucose levels may be lower in the brains of AD patients, and their brain cells may also use glucose less well than in unaffected people. The proper function of brain cells may be critical to memory and thought. If brain cells use glucose poorly, this might impact AD. Drugs that help brain cells properly use glucose may help a person maintain normal memory and thinking. Data suggesting that RSG may help AD patients was first seen in a small study at the Univ. of Washington and then from a larger international GSK study. In the first study, those receiving RSG once daily for 6 months scored better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that benefited most from therapy with RSG XR had a specific genetic pattern. They lacked the gene that caused them to produce apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene from one parent. Subjects with one copy of the APOE e4 gene remained fairly stable while those with two copies of APOE e4 continued to worsen during the 6-month treatment. This study will directly test the effect of RSG XR on people who either have or lack the APOE e4 gene.

NCT ID: NCT00425555 Completed - Clinical trials for Cutaneous T-Cell Lymphoma

Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma

Start date: January 2007
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.

NCT ID: NCT00424502 Completed - Clinical trials for Rheumatoid Arthritis

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.

Start date: January 2007
Phase: Phase 4
Study type: Interventional

This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

NCT ID: NCT00424268 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)

HELIOS
Start date: January 2007
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

NCT ID: NCT00424255 Completed - Clinical trials for Neoplasms, Head and Neck

Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery

Start date: December 2006
Phase: Phase 3
Study type: Interventional

This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with head and neck cancer following surgery. Lapatinib or placebo will be administered post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing the recurrence of the disease in these high-risk patients.

NCT ID: NCT00423319 Completed - Pulmonary Embolism Clinical Trials

Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)

Start date: March 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied

NCT ID: NCT00423098 Completed - Lupus Nephritis Clinical Trials

Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

Start date: February 2007
Phase: Phase 2
Study type: Interventional

The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in combination with two different corticosteroid (CS) regimes for the induction of remission of a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group I) or to a reduced dose CS regimen (group II)

NCT ID: NCT00422383 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)

Start date: February 2006
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

NCT ID: NCT00421993 Completed - Acne Vulgaris Clinical Trials

A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Start date: October 2006
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study. The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.