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NCT ID: NCT00549198 Completed - HIV Infection Clinical Trials

KIVEXA Vs TRUVADA, Both Administered With Efavirenz, In ART-Naive Subjects

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

Recently, the fixed-dose combinations (FDC) KIVEXA™ (abacavir/lamivudine) and TRUVADA (tenofovir disoproxil fumarate/emtricitabine) have facilitated the usage of once-daily regimens. However data from head-to-head randomized trials comparing these two FDCs as part of an initial regimen are not available at present. The long-term toxicity profiles of these regimens are of particular importance, as treatment of HIV is currently life-long and therefore, minimizing long-term toxicity and maximizing adherence and duration of regimen maintenance are critical therapy objectives. The primary endpoint is estimated glomerular filtration rate (GFR), as measured by the modified diet in renal disease (MDRD) equation, a validated estimate of renal function.

NCT ID: NCT00545532 Completed - Influenza, Human Clinical Trials

A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.

Start date: February 4, 2008
Phase: Phase 3
Study type: Interventional

This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams [mg] to 75 mg twice daily orally [po], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.

NCT ID: NCT00545363 Completed - Clinical trials for Postmenopausal Osteoporosis

A Study of Adherence to Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP).

Start date: May 2006
Phase: Phase 4
Study type: Interventional

This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using serum CTX and communication of results at 3 months, on adherence to once monthly Bonviva (150mg po) in women with post-menopausal osteoporosis supported by PRP. Patients will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

NCT ID: NCT00545129 Completed - Neoplasm Metastasis Clinical Trials

A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone

Start date: April 29, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.

NCT ID: NCT00538356 Completed - Clinical trials for Congestive Heart Failure

Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function

IN-TIME
Start date: July 2007
Phase: Phase 4
Study type: Interventional

Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate variability, or ventricular ectopy. The Home Monitoring™ capability offered by BIOTRONIK active implants has the potential to detect some of these trends early and thus to offer the possibility to intervene in time for prevention of fatal worsening of heart failure. To investigate the predictive value of Home Monitoring parameters, patients with symptomatic heart failure and reduced ejection fraction receiving an implantable cardioverter-defibrillator (ICD) or an ICD in combination with cardiac resynchronization therapy (CRT-D) will be randomized between prospective patient management by Home Monitoring analysis or standard care. The influence of Home Monitoring on the clinical status of heart failure patients will be assessed.

NCT ID: NCT00535691 Completed - Dermatitis, Atopic Clinical Trials

Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis

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

The purpose of this study is to estimate the systemic exposure to tacrolimus in infants with atopic dermatitis after repeated application of tacrolimus ointment. Efficacy of tacrolimus ointment, evaluated by examination of treated areas, will also be measured.

NCT ID: NCT00532558 Terminated - Clinical trials for Hypercholesterolemia

Efficacy of Lapaquistat Acetate on Blood Cholesterol Levels in Treating Subjects With Hypercholesterolemia

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

The purpose of the study is to determine the reduction of LDL-cholesterol level after treatment with 50 mg per day of lapaquistat acetate once daily (QD).

NCT ID: NCT00525213 Completed - Clinical trials for Rheumatoid Arthritis

Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 When Added to Methotrexate

ROBUST
Start date: October 2007
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy (ACR20) of Rob 803 administered orally once daily for 12 weeks in combination with a stable dose of methotrexate in subjects with moderate or severe active RA.

NCT ID: NCT00509145 Completed - Multiple Sclerosis Clinical Trials

Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS)

ALLEGRO
Start date: November 13, 2007
Phase: Phase 3
Study type: Interventional

Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).

NCT ID: NCT00509106 Completed - Bacterial Pneumonia Clinical Trials

Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia

CAP
Start date: July 2007
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.