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NCT ID: NCT00647504 Completed - Stent Thrombosis Clinical Trials

Prospective Clinical Observational Registry Including Consecutive Patients With In-stent Restenosis or Stent Thrombosis

NIVUS
Start date: October 2007
Phase: N/A
Study type: Observational

Prospective clinical observational registry study including consecutive patients with clinical signs or symptoms due to in-stent restenosis (ISR) or definite (ARC criteria) stent thrombosis (ST). Study hypothesis: Initial Stent implantation quality (due to technique/problems) are possible major determinants of ST and ISR in real life practice. Both early, late, and very late ST, and ISR are important factors for long term outcome after initial stent implantation. Primary objective: - To elucidate the possible cause(s) of thrombosis or restenosis after stent implantation in real life practice by clinical, angiographic and IVUS evaluation. Secondary objective: - To describe the clinical manifestation [stable angina pectoris (AP), unstable AP, non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation MI] of the index event (inclusion). - To describe the characteristics of patient, lesion and procedure of the initial percutaneous coronary intervention (PCI). - To describe the antithrombotic pharmacological therapy preceding the index event. - To describe clinical outcome (death, MI, revascularization, CCS angina class) following treatment of the index event during 12 month follow-up. - To describe safety of the IVUS procedure (product or procedural related complications/ malfunctions).

NCT ID: NCT00645099 Completed - Schizophrenia Clinical Trials

A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia

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

The purpose of this 6 month study is to compare the metabolic effects of paliperidone ER and olanzapine in patients with schizophrenia, using the ratio of the concentration of lipids (triglycerides (TG)) in the blood to the concentration of good cholesterol (high density lipoproteins (HDL)) in the blood as the primary parameter. Approximately 456 adult patients will participate in this study.

NCT ID: NCT00642148 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A 12 Week Study To Assess Efficacy And Safety Of GW856553 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: February 14, 2008
Phase: Phase 2
Study type: Interventional

Phase IIa, randomised, double-blind, double-dummy, parallel group, multi-centre study in subjects diagnosed with moderate chronic obstructive pulmonary disease (COPD). The primary objective is to evaluate the effects of 12-weeks of treatment with GW856553 7.5 mg twice daily (BID) compared with placebo on the percentage of sputum neutrophils at 12 weeks. Twelve weeks of treatment with SERETIDE 50/500 BID will be compared with placebo for effect on sputum neutrophils as a positive control arm in the study

NCT ID: NCT00641537 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

CLARITY Extension Study

Start date: February 29, 2008
Phase: Phase 3
Study type: Interventional

The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week treatment.

NCT ID: NCT00637377 Completed - Clinical trials for Macular Degeneration

Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)

VIEW 2
Start date: April 2008
Phase: Phase 3
Study type: Interventional

This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.

NCT ID: NCT00636740 Completed - Clinical trials for Hormone-Refractory Prostate Cancer

Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients

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

The objective of MER-101-03 is to examine the effects of two different dosing regimens of MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be enrolled will be those who have not received any previous bisphosphonate therapy. The study will be carried out on prostate cancer patients who are no longer on hormone therapy. Treatment in the study will be for a 2-month period.

NCT ID: NCT00630279 Terminated - Clinical trials for Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

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

This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency

NCT ID: NCT00626548 Terminated - Prostate Cancer Clinical Trials

A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer

ENTHUSE M0
Start date: January 2008
Phase: Phase 3
Study type: Interventional

Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments. ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases. All patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy. Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour. No patients will be deprived of standard prostate cancer therapy.

NCT ID: NCT00625898 Terminated - Breast Cancer Clinical Trials

BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab

BETH
Start date: April 2008
Phase: Phase 3
Study type: Interventional

The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer.

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.