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NCT ID: NCT00280566 Completed - Bipolar Disorder Clinical Trials

Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)

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

The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.

NCT ID: NCT00253955 Completed - Pneumonia Clinical Trials

Study to Demonstrate the Clinical Efficacy of Levofloxacin in the Treatment of Pneumonia

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

Primary Objective: - The primary objective of the study is to demonstrate the non-inferiority in clinical efficacy at the test of cure (TOC) visit planned 5-7 days after treatment completion of levofloxacin 750 mg once daily (od) in comparison with piperacillin/tazobactam 4 g/500 mg every 8 hours in treating adult patients suffering from mild to moderate hospital-acquired pneumonia. Secondary Objectives: The secondary objectives of the study are: - To assess the bacteriological efficacy at the test of cure (TOC) visit - To assess the clinical and bacteriological efficacy at the end of study (EOS) visit, 28 to 32 days after treatment ends - To assess the tolerability of both drugs

NCT ID: NCT00245739 Approved for marketing - HIV Infections Clinical Trials

TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.

Start date: n/a
Phase: Phase 3
Study type: Expanded Access

The purpose of this study is to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients with limited or no treatment options, who have failed multiple antiretroviral (ARV) regimens, and to evaluate the longer-term safety and tolerability of TMC114/r in combination with other antiretrovirals

NCT ID: NCT00242801 Completed - NSCLC Clinical Trials

Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

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

This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.

NCT ID: NCT00239681 Terminated - Clinical trials for Elevated High-sensitivity C-Reactive Protein (hsCRP)

JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events

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

The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.

NCT ID: NCT00237146 Completed - Prostate Cancer Clinical Trials

Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy

Start date: November 2003
Phase: Phase 4
Study type: Interventional

An open, multicenter and prospective study to evaluate the impact of the treatment with zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with prostate cancer and bone metastasis that responds to hormonal therapy. Zoledronic acid is given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event occurs.

NCT ID: NCT00232180 Completed - Heart Failure Clinical Trials

A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines

EMPHASIS-HF
Start date: March 2006
Phase: Phase 3
Study type: Interventional

In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients. The Data Safety Monitoring Committee (DSMC) observed during its conduct of the protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. As a result of the discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone. The Open Label Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for the indication studied in this patient population. On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone

NCT ID: NCT00171340 Completed - Breast Cancer Clinical Trials

Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

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

Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.

NCT ID: NCT00166244 Completed - Clinical trials for De Novo Renal Transplant Recipient.

Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation

Start date: May 2003
Phase: Phase 4
Study type: Interventional

Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.

NCT ID: NCT00156078 Completed - Clinical trials for Diabetic Neuropathy, Painful

A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)

Start date: January 2005
Phase: Phase 4
Study type: Interventional

A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).