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NCT ID: NCT00533793 Completed - Trauma Clinical Trials

Adjunctive Therapy to Treat Tibial Shaft Fractures

TSF
Start date: April 2007
Phase: Phase 2
Study type: Interventional

A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or 1.0 mg/mL I-040202.

NCT ID: NCT00532155 Completed - Carcinoma Clinical Trials

A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

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

The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). The secondary objectives were to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this participant population and to determine immunogenicity of IV aflibercept in all participants.

NCT ID: NCT00529529 Completed - Asthma Clinical Trials

Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma

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

This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily [od]), compared with salmeterol (50 μg twice a day [b.i.d.]), over 26 weeks, in patients with moderate to severe persistent asthma.

NCT ID: NCT00528996 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.

Start date: September 6, 2007
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.

NCT ID: NCT00528970 Completed - Ileus Clinical Trials

A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair

Start date: October 17, 2007
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of two different dose regimens (12 milligrams [mg] and 24 mg) of IV MOA-728 versus placebo in shortening the time to return of bowel function in participants receiving opioid analgesia administered via patient-controlled anesthesia (PCA), and who had undergone repair of large (greater than or equal to [≥]10 centimeters) ventral hernias with or without a mesh prosthesis via laparotomy or laparoscopy.

NCT ID: NCT00528112 Completed - Contraception Clinical Trials

Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

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

This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years

NCT ID: NCT00528073 Completed - Crohn's Disease Clinical Trials

Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease

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

This study aims to determine which of 3 doses of a non-absorbable antibiotic Rifaximin is most effective in treating active moderate Crohn's disease. Rifaximin tablets are already marketed in some European countries and the USA to treat traveller's diarrhoea. A new gastro-resistant form of Rifaximin called Rifaximin-Extended Intestinal Release (EIR) will be used in this study. These tablets dissolve in the stomach,releasing gastro-resistant granules which pass into the intestines and deliver Rifaximin directly to the site of the disease. Rifaximin is not absorbed, making it more effective and greatly reducing the frequency of side effects.

NCT ID: NCT00526136 Completed - Atrial Fibrillation Clinical Trials

Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study

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

To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg, 300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained symptomatic atrial fibrillation (AF duration > 72 hours and < 6 months).

NCT ID: NCT00524433 Completed - Acute Heart Failure Clinical Trials

Tezosentan in the Treatment of Acute Heart Failure

VERITAS 2
Start date: April 2003
Phase: Phase 3
Study type: Interventional

The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up period of 5 months for vital status.

NCT ID: NCT00524368 Completed - Clinical trials for Human Immunodeficiency Virus - Type 1

A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)

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

The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).