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NCT ID: NCT00625235 Completed - Obesity Clinical Trials

A High Protein Diet and Weight Maintenance

Start date: July 2003
Phase: N/A
Study type: Interventional

An investigation into long term weight maintenance using a high protein or high carbohydrate diet, after a large and rapid weight loss.

NCT ID: NCT00625196 Completed - Asthma Clinical Trials

Comparing Two Respiratory Drugs in Combination and Separately From a Novel Inhaler Device in Healthy Japanese Subjects

Start date: February 27, 2008
Phase: Phase 1
Study type: Interventional

A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is being developed for once daily administration for the maintenance treatment of asthma and COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and compared with GW642444M and GW685698X administered separately in order to determine whether co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics of either compound in healthy Japanese subjects.

NCT ID: NCT00624468 Terminated - Optic Neuritis Clinical Trials

Atacicept in Subjects With Optic Neuritis

Start date: June 2008
Phase: Phase 2
Study type: Interventional

This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.

NCT ID: NCT00624338 Completed - Clinical trials for Lupus Erythematosus, Systemic

Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)

APRIL-SLE
Start date: January 2008
Phase: Phase 2/Phase 3
Study type: Interventional

This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.

NCT ID: NCT00624052 Completed - Hypertension Clinical Trials

26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension

Start date: March 2008
Phase: Phase 3
Study type: Interventional

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months. An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension. The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP < 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).

NCT ID: NCT00623727 Terminated - Hemophilia A Clinical Trials

BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

Start date: June 2008
Phase: Phase 2
Study type: Interventional

A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.

NCT ID: NCT00623428 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

Start date: June 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.

NCT ID: NCT00623103 Completed - Clinical trials for Parkinson's Disease Dementia

Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)

Start date: January 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.

NCT ID: NCT00622869 Completed - Clinical trials for Liver Transplantation

Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

RAD
Start date: January 2008
Phase: Phase 3
Study type: Interventional

This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.

NCT ID: NCT00622700 Active, not recruiting - Multiple Sclerosis Clinical Trials

Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis

TOPIC
Start date: February 2008
Phase: Phase 3
Study type: Interventional

The primary objective is to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS). The secondary objectives are: - To demonstrate the effect of teriflunomide, in comparison to placebo, on: - Reducing conversion to definite multiple sclerosis (DMS) - Reducing annualized relapse rate (ARR) - Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI) - Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS) - Proportion of disability-free participants as assessed by the EDSS - Reducing participant-reported fatigue - To evaluate the safety and tolerability of teriflunomide - To evaluate the pharmacokinetics (PK) of teriflunomide - Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes