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NCT ID: NCT01009047 Completed - Schizophrenia Clinical Trials

An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia

Start date: December 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of extended-release (ER) paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations [imagining things], and withdrawal into the self) .

NCT ID: NCT01007435 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

Start date: October 2009
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.

NCT ID: NCT01006629 Completed - Clinical trials for Congenital Heart Disease

Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children

Start date: November 2009
Phase: Phase 2/Phase 3
Study type: Interventional

100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial virus (RSV) infection in order to study the safety and efficacy of the drug in Russian subjects.

NCT ID: NCT01006291 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes

BEGIN™
Start date: November 2009
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stable, prerandomisation dose level and dosing frequency.

NCT ID: NCT01006265 Completed - Multiple Sclerosis Clinical Trials

Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis

Start date: October 1, 2009
Phase: Phase 2
Study type: Interventional

This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

NCT ID: NCT01006135 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region

Start date: October 2009
Phase: N/A
Study type: Observational

The objective of this observational study is to collect and evaluate data on Health Related Quality of Life (HRQoL) of Spiriva delivered by HandiHaler, using disease specific SGRQ in the national samples of Central & Central European patients with varying severities of chronic obstructive pulmonary disease (COPD) in the real life setting over the 6 months.

NCT ID: NCT01005901 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo

GLOW 1
Start date: October 2009
Phase: Phase 3
Study type: Interventional

A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

NCT ID: NCT01004081 Completed - Breast Cancer Clinical Trials

Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy, safety and tolerability of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal aromatase inhibitor (AI).

NCT ID: NCT01004029 Completed - Preterm Birth Clinical Trials

Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery

PROLONG
Start date: October 2009
Phase: Phase 3
Study type: Interventional

As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singleton pregnancy, aged 18 years or older, with a previous singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship and the effect of body mass index (BMI) on the PK of 17P.

NCT ID: NCT01003990 Completed - HIV Clinical Trials

Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

Start date: October 2002
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial