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NCT ID: NCT00164450 Completed - Tuberculosis Clinical Trials

TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection

Start date: September 2005
Phase: N/A
Study type: Interventional

Compared to adults, children appear to require higher weight-based doses of rifapentine to acheive comparable drug levels. TBTC Study 26, a study of the effectiveness and tolerability of weekly rifapentine/isoniazid for three months versus daily isoniazid for nine months for the treatment of latent tuberculosis infection, has been amended to include children ages 2-11 based on an initial single-dose study and pharmacokinetic modeling. Study 26PK evaluates the adequacy of the doses chosen for young children enrolled in Study 26 with a single blood draw, 24 hours after the third or subsequent weekly Study 26 dose of rifapentine and isoniazid. An adult control is enrolled for each child enrolled.

NCT ID: NCT00163462 Completed - Asthma Clinical Trials

Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)

Start date: October 2004
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled once daily, using one of the two dose levels; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.

NCT ID: NCT00163449 Completed - Asthma Clinical Trials

Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)

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

The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

NCT ID: NCT00162331 Completed - Clinical trials for Myocardial Infarction

CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI

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

The purpose of this clinical study is to learn if there are any changes in how blood gets to your heart muscle and if your heart size changed after your heart attack.

NCT ID: NCT00162240 Completed - Diabetes Mellitus Clinical Trials

PPAR - Combination With Metformin

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

A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

NCT ID: NCT00162175 Completed - Clinical trials for Metabolics Diabetes Nos

PPAR-COMBO With Sulfonylurea

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

A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.

NCT ID: NCT00162123 Completed - Melanoma Clinical Trials

A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies

Start date: May 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.

NCT ID: NCT00162032 Completed - Kawasaki Disease Clinical Trials

A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease

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

Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.

NCT ID: NCT00160849 Completed - HIV Infections Clinical Trials

Lopinavir/r Monotherapy as Maintenance Therapy After Long Term Viral Suppression

Start date: August 2004
Phase: Phase 4
Study type: Interventional

1. Objectives Primary - To investigate the possibility of maintaining virological suppression of HIV in infected patients, switching them to LPV/r as the only antiretroviral agent - To assess the immunological response in patients who switched to LPV/r as single agent, based on the observation of changes in the serum levels of CD4+ cells. Secondary - To investigate the rate of clinical and laboratorial adverse events in the two treatment groups. - To investigate the rate of emergence of antiretroviral resistance mutations in the two treatment groups, in case of virological failure of the current regimen. - To describe the adherence to the prescribed regimen in the two treatment groups - To describe changes in body fat distribution (abdominal, arms and thigh circumference) and in the lipid profile, in patients from the two treatment groups - To describe the rate of clinical failure of the antiretroviral therapy in the two treatment groups. 2. Patient population: The 60 patients were selected by the investigators according to the study’s inclusion and exclusion criteria, and were divided into 2 groups with 30 patients each. 3. Study design: The study is multicentric, open-label, randomized. Virological, immunological and clinical failures will be analyzed in both groups. In addition, data on clinical or laboratorial toxicity and compliance are being recorded. 4. Regime: - Group 1 maintenance of the currently used antiretroviral therapy - Group 2 switch to LPV/r antiretroviral monotherapy in the dose of 400/100 mg 12/12 hs with food. Patients in group 2 who were being treated previously with non-nucleoside reverse transcriptase inhibitors (Efavirenz or Nevirapine) were instructed to take 4 capsules of Lopinavir/r each 12 hs, during the first 14 days of therapy (up to Week 2 visit). 5. Duration: 96 weeks of treatment

NCT ID: NCT00159913 Completed - Clinical trials for Pulmonary Arterial Hypertension, Children

A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.

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

This is a clinical research study designed to evaluate sildenafil for the treatment of Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with oral sildenafil given in three different doses, compared to placebo (inactive treatment). Efficacy will be measured by exercise and hemodynamics. Patients who complete this trial may be eligible to take part in an extension study, in which all patients will receive active treatment of sildenafil.