Clinical Trials Logo

Filter by:
NCT ID: NCT01311648 Completed - Haemophilia A Clinical Trials

BAY81-8973 Pediatric Safety and Efficacy Trial

Start date: June 9, 2011
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the safety and efficacy of the treatment with BAY81-8973 for prophylaxis and treatment of breakthrough bleeds in children with severe hemophilia A. The secondary objectives were - To assess the safety and efficacy of BAY81-8973 during surgeries. - To assess incremental recovery of BAY81-8973. - To assess pharmacokinetic (PK) parameters in a subset of children (Previously treated patients [PTPs] and previously untreated patients [PUPs] / minimally treated patients [MTPs] - participation in PK sampling was voluntary and required consent).

NCT ID: NCT01309737 Completed - Psoriasis Clinical Trials

A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

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

The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.

NCT ID: NCT01308580 Completed - Prostate Cancer Clinical Trials

Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer

PROSELICA
Start date: April 2011
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate the non inferiority in term of overall survival (OS) of cabazitaxel 20 mg/m² (Arm A) versus cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in patients with metastatic castration resistant prostate cancer (MCRPC) previously treated with a docetaxel-containing regimen. Secondary Objectives: - To evaluate safety in the 2 treatment arms and to assess if cabazitaxel 20 mg/m² is better tolerated than cabazitaxel 25 mg/m². - To compare efficacy of cabazitaxel at 20 mg/m² and 25 mg/m² for: - Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), PSA progression, pain progression or death due to any cause - Prostate-Specific Antigen (PSA)-Progression - Pain progression - Tumor response in patients with measurable disease (RECIST 1.1). - PSA response - Pain response in patients with stable pain at baseline. - To compare Health-related Quality of Life (HRQL) - To assess the pharmacokinetics and pharmacogenomics of cabazitaxel

NCT ID: NCT01307423 Completed - Psoriatic Arthritis Clinical Trials

Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)

PALACE4
Start date: December 9, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis who have not been previously treated with DMARDs. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

NCT ID: NCT01307397 Completed - Malignant Melanoma Clinical Trials

A Study of Vemurafenib in Participants With Metastatic Melanoma

Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.

NCT ID: NCT01307020 Completed - Pain Clinical Trials

Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain

DEX-TRA 02
Start date: February 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.

NCT ID: NCT01306461 Completed - Ocular Hypertension Clinical Trials

Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations

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

The purpose of this study is to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of tafluprost and timolol. This study will enroll patients who have ocular hypertension or glaucoma. The study schedule includes seven visits to the study site and three stages: - washout of 5 days to 4 weeks depending on current glaucoma medication (if any) - 6-month study treatment period - 1-3 weeks post-study period

NCT ID: NCT01305408 Completed - Depression Clinical Trials

Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

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

The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.

NCT ID: NCT01304836 Completed - Clinical trials for Kidney Transplantation

A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids

ADVANCE
Start date: January 22, 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.

NCT ID: NCT01303796 Completed - Clinical trials for Acute Myeloid Leukemia

A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

SEAMLESS
Start date: October 1, 2011
Phase: Phase 3
Study type: Interventional

This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.