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NCT ID: NCT00809965 Completed - Clinical trials for Myocardial Infarction

An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

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

The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

NCT ID: NCT00808977 Completed - Ulcerative Colitis Clinical Trials

A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis

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

The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.

NCT ID: NCT00808288 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.

A7881013
Start date: March 2010
Phase: Phase 2
Study type: Interventional

To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)

NCT ID: NCT00808132 Completed - Osteoporosis Clinical Trials

Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

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

The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.

NCT ID: NCT00808067 Completed - Atrial Fibrillation Clinical Trials

RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

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

The purposes of this study are: 1. To evaluate the long-term safety of dabigatran etexilate 2. To assess the effect of a knowledge translation intervention on patient outcomes

NCT ID: NCT00806923 Completed - Clinical trials for Non-Squamous Non-Small Cell Lung Cancer

A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Start date: February 2005
Phase: Phase 3
Study type: Interventional

This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

NCT ID: NCT00806819 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC

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

The trial will be performed to evaluate if BIBF 1120 in combination with standard pemetrexed therapy is more effective than placebo (inactive capsule) plus standard pemetrexed therapy in patients with stage IIIB, IV or recurrent NSCLC. Safety information about BIBF1120/pemetrexed will be obtained.

NCT ID: NCT00805350 Completed - Primary Insomnia Clinical Trials

Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties

ECLIPSE
Start date: December 2008
Phase: Phase 3
Study type: Interventional

Primary objective: - To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients, as measured by Polysomnography Wake Time After Sleep Onset (PSG-WASO) and Polysomnography Number of Awakenings (PSG-NAW). Secondary objectives: - To evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of treatment on other sleep parameters measured by PSG recordings (Total Sleep Time - PSG-TST, Sleep Efficiency - PSG-SE, Latency to Persistent Sleep - PSG-LPS) and reported by patients (Wake Time After Sleep Onset - pr-WASO, Number of Awakenings - pr-NAW, Total Sleep Time - pr-TST, Quality of Sleep - QoS and Refreshing Quality of Sleep - RqoS). - To evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to placebo. - To evaluate the effect of eplivanserin 5mg/day on daytime functioning using the Sleep Impact Scale (SIS), as compared with placebo after 6 weeks of treatment. - To evaluate patient's impression of treatment effects using the Patient's Global Impression questionnaire. - To evaluate the potential for next-day residual effects (using patient's morning questionnaire and psychometric tests) with eplivanserin 5mg/day as compared to placebo. - To evaluate the potential for rebound insomnia following abrupt discontinuation of eplivanserin 5mg/day in comparison with placebo. - To evaluate the effect of eplivanserin, compared to placebo, on the quality of life of patients with primary insomnia using the SF-36 Health Survey. - To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo.

NCT ID: NCT00805168 Completed - Clinical trials for Pneumonia, Bacterial

Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

INHALE 2
Start date: May 28, 2013
Phase: Phase 3
Study type: Interventional

To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on ventilation, and the days in the intensive care unit (ICU).

NCT ID: NCT00802373 Completed - Clinical trials for Urinary Bladder, Overactive

Solifenacin Succinate Versus Tolterodine 4mg Once Daily

STAR
Start date: July 2003
Phase: Phase 3
Study type: Interventional

Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries.