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NCT ID: NCT00627926 Completed - Hepatitis C Clinical Trials

A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)

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

A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

NCT ID: NCT00627679 Completed - Asthma Clinical Trials

Safety and Blood Level Study of Unit Dose Budesonide

UDB P101
Start date: December 2005
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.

NCT ID: NCT00627640 Completed - Clinical trials for Idiopathic Parkinson's Disease

Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa

SETTLE
Start date: February 2009
Phase: Phase 3
Study type: Interventional

Parkinson's Disease is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the major DA metabolising enzyme in man. Safinamide is an inhibitor of MAO-B. This is a phase III trial to evaluate the efficacy and safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a stable dose to levodopa in subjects with advance idiopathic Parkinson's Disease. The principal efficacy measure is the increase in mean daily "on" time during the 18-hr diary recording period.

NCT ID: NCT00627328 Completed - Atrial Fibrillation Clinical Trials

The Atrial High Rate Episodes in Pacemaker Patients

Start date: July 2000
Phase: N/A
Study type: Observational

Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker patients with and without previously diagnosed AT.

NCT ID: NCT00626522 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Aclidinium/Formoterol Fixed Combination Dose Finding Study

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

The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for investigation in Phase III clinical trials

NCT ID: NCT00626106 Completed - Breast Cancer Clinical Trials

QUILT-2.015: A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

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

This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic disease.

NCT ID: NCT00625846 Completed - Clinical trials for Recurrent Thyroid Gland Carcinoma

Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer

Start date: February 22, 2008
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects and how well pazopanib hydrochloride works in treating patients with advanced thyroid cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood flow to the tumor.

NCT ID: NCT00625664 Completed - Clinical trials for Urinary Bladder Neoplasms

Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer

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

This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.

NCT ID: NCT00625612 Completed - Cystic Fibrosis Clinical Trials

Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease

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

The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.

NCT ID: NCT00625378 Completed - Neoplasms Clinical Trials

Sorafenib Long Term Extension Program

STEP
Start date: December 21, 2007
Phase: Phase 3
Study type: Interventional

The primary purpose of program was to enable patients, currently receiving sorafenib (Nexavar) in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after their respective study had met its primary endpoint and/or had reached the end as defined in the original protocol. Patients were able to continue treatment until (i) the treating physician felt the patient was no longer benefiting from the treatment or (ii) the treatment becomes commercially available and reimbursed for the respective indication as applicable in the country in which the patient lived and the patient could obtain suitable amounts of drug for treatment through standard mechanisms of commercial availability (ie, there should be no interruption in the patient's treatment schedule when switching to commercially available product) or (iii) the patient could join a Post-Trial-Access Program, another study or can receive sorafenib through any other mechanism (e.g. local access program) in accordance with local legal and compliance rules, with no cost to the patient with respect to sorafenib. An additional objective was the assessment of the safety of Nexavar or Nexavar combination treatment.