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NCT ID: NCT00679900 Completed - Clinical trials for Sleep Initiation and Maintenance Disorders

Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties

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

The primary objective is to compare the potential for next-day residual effects of eplivanserin 5 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties. The secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.

NCT ID: NCT00679627 Terminated - Alzheimer's Disease Clinical Trials

A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease

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

The purpose of this study is to compare the effectiveness and safety of 2 years of treatment with galantamine as compared with placebo of patients who have mild to moderately severe Alzheimer's disease (AD).

NCT ID: NCT00679588 Completed - Clinical trials for Venous Thromboembolism

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

SAVE-ABDO
Start date: April 2008
Phase: Phase 3
Study type: Interventional

The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery. The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.

NCT ID: NCT00679380 Completed - Ulcerative Colitis Clinical Trials

(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

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

This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period. After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.

NCT ID: NCT00677053 Completed - Clinical trials for Acute Coronary Syndrome

Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes

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

The purpose of this study is to determine the safety and tolerability of multiple doses of TAK-442once daily, (QD) or twice daily (BID), in subjects with acute coronary syndrome (unstable angina, myocardial infarction).

NCT ID: NCT00670007 Completed - Emphysema Clinical Trials

Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.

Start date: April 2008
Phase: Phase 4
Study type: Interventional

This study is a continuation of the placebo-controlled study CE1226_4001 (NCT00261833) to evaluate the efficacy and safety of Zemaira® i.v. administration in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The long-term verification of a disease-modifying benefit of Zemaira® on the progression of emphysema will be assessed by volume-adjusted lung density, measured yearly by computed tomography (CT).

NCT ID: NCT00668772 Terminated - Clinical trials for Pulmonary Disease, Chronic Obstructive

Tiotropium/Salmeterol Inhalation Powder in COPD

Start date: April 15, 2008
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined bt the SGRQ and the effect on COPD exacerbations

NCT ID: NCT00668759 Completed - Atrial Fibrillation Clinical Trials

A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation

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

The primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of drug administration. The secondary objective is to compare the safety of vernakalant to amiodarone.

NCT ID: NCT00664170 Completed - Advanced Cancer Clinical Trials

A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer

Start date: April 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.

NCT ID: NCT00662740 Terminated - Clinical trials for Pulmonary Disease, Chronic Obstructive

Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD)

Start date: April 15, 2008
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index/Transition Dyspnoea Index (BDI/TDI), the effect on health status as determined by the St George Respiratory Questionnaire (SGRQ) and the effect on chronic obstructive pulmonary disease (COPD) exacerbations.