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NCT ID: NCT00478881 Completed - Overactive Bladder Clinical Trials

A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function

Start date: August 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess if the study drug, Vardenafil (approved by Health Authorities is available on the market for treatment of erectile dysfunction) has an effect on bladder function and micturition frequency. The study drug is to be taken in the form of tablets twice a day, one tablet in the morning and one tablet in the evening. A non-active treatment (placebo), a sugar pill, will be used as a comparator to see if the new study drug works better than no drug. The timing of visits for the study is as follows: the 1st visit (screening visit) at beginning of run-in-assessment with qualifying tests for patients: electrocardiogram (ECG), safety laboratory and residual urine (by ultrasonography: a non-invasive examination using ultrasound for the assessment of the bladder). 2nd visit (randomization visit). During visit this should be performed: urodynamic measurements (filling cystometry and pressure flow investigations), ECG and safety laboratory. 3rd visit (safety visit) takes place at two up to three weeks of randomized treatment. 4th visit (final visit)-following test should be done: urodynamic measurements (filling cystometry and pressure flow investigations), ECG, safety laboratory and residual urine (by ultrasonography); A phone call 24 hours after visit 4 to assess any SAEs.

NCT ID: NCT00478660 Completed - Clinical trials for Ankylosing Spondylitis

An Open-Label Study to Evaluate the Response to Adalimumab in Patients With Active Ankylosing Spondylitis Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)

RHAPSODY
Start date: February 2006
Phase: Phase 3
Study type: Interventional

Due to the rigor of the clinical development program of adalimumab for the indication of AS, the population of subjects with active AS that could enroll in previous phase 3 studies was limited. Therefore, it is necessary to further evaluate the use of adalimumab in a setting that mimics day-to-day clinical practice to obtain further safety and efficacy data by allowing subjects meeting the characteristics noted below to enter this study: - Subjects who failed another TNF inhibitor (etanercept, infliximab) - Subjects with advanced spinal ankylosis - Subjects with AS associated disorders (i.e., uveitis, IBD, and psoriasis)

NCT ID: NCT00477984 Completed - Alcoholism Clinical Trials

Effects of Alcohol on Simulated Driving

Start date: May 2007
Phase: N/A
Study type: Interventional

Previous studies have shown that alcohol significantly impairs driving performance. Acute alcohol administration also has a detrimental effect on secondary task performance during dual-tasks. The present study will investigate the effects of five different dosages of ethanol (0,0.2, 0,5, 0,8 and 1,0 % BAC) on performance in a driving simulator. Steering performance and brain activity will be recorded in both single- and dual-task conditions.

NCT ID: NCT00476957 Completed - Clinical trials for Ischemic Heart Disease

Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)

PROTECT
Start date: June 2007
Phase: Phase 4
Study type: Interventional

The PROTECT TRIAL is a randomized stent trial with 8800 patients in approximately 200 hospitals, which is designed to evaluate whether the Endeavor stent PROTECTS against late stent thrombosis resulting in less deaths and myocardial infarctions. Study Stents: Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System or next generation model Cordis Cypher® Sirolimus-eluting Coronary Stent, Cordis Cypher Select® Sirolimus-eluting Coronary Stent or next generation model Primary Objective: To compare overall stent thrombosis rate of the Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation Secondary Objective: To compare the composite endpoint of total death or cardiac death combined with the number of patients with all non-fatal myocardial infarctions as well as the number of patients with large non-fatal myocardial infarctions for Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation. To assess the safety and efficacy in patient subgroups with specific demographics, clinical indications and/or vessel- or lesion characteristics.

NCT ID: NCT00476034 Completed - Osteoarthritis Clinical Trials

Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)

Start date: December 2003
Phase: Phase 3
Study type: Interventional

This 39-week, active controlled, study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2361 study.

NCT ID: NCT00475852 Completed - Clinical trials for Heart Decompensation

A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure

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

The purpose of this study is to find out if nesiritide (a human B-type natriuretic peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart failure, helps to improve breathing difficulties, reduce heart failure readmissions to hospitals, and helps patients live longer.

NCT ID: NCT00475774 Completed - Obesity Clinical Trials

Body Fat Distribution and Fat Metabolism

Start date: May 2007
Phase: N/A
Study type: Interventional

The primary purpose of the study is to examine the effect of body fat distribution on the physiological response to a dietary fat intervention. Physiological response will be evaluated as fatty acid kinetics (plasma and subcutaneous fat appearance). Secondary objectives are targeted protein production (apoB and adiponectin). Examination of the effect of chain length of the dietary fatty acids on fat tissue characteristics and the effect of chain length on satiety, will be studied as well.

NCT ID: NCT00475371 Completed - Clinical trials for Diabetes Mellitus, Type 2

A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males

Start date: April 2007
Phase: Phase 1
Study type: Interventional

26 subjects will be enrolled into 5 different dose groups. The trial will consist of a screening, a dosing and a follow-up visit. Dosing at visit 2, of MKC253 Inhalation Powder, Glucagon-Like Peptide-1 (GLP-1) will be given at 5 dose levels.

NCT ID: NCT00474786 Completed - Clinical trials for Renal Cell Carcinoma

Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib

INTORSECT
Start date: September 2007
Phase: Phase 3
Study type: Interventional

This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.

NCT ID: NCT00473772 Completed - Clinical trials for Coronary Artery Disease

DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease

PEPCADIII
Start date: July 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting SeQuent Please S stent system (DEBlue) in the treatment of stenoses in native coronary arteries with nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and < 24 mm in length for procedural success and preservation of vessel patency in comparison to the Sirolimus-eluting CypherTM stent.