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NCT ID: NCT01782326 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study

Start date: July 2013
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.

NCT ID: NCT01780948 Completed - Clinical trials for Difference of 12-hour AUC

Pharmacokinetic of Everolimus and Atorvastatin Co-administration

Start date: September 2012
Phase: N/A
Study type: Interventional

Hypothesis : In renal transplantation recipient who received immunosuppressive drug "certican" and have hypercholesterolemia will get lipid lower drug-HMG Co-A reductase inhibitors. Because atorvastatin and everolimus have metabolism via Cytochrome P450 subfamily 3A4 both, so investigator made the hypothesis that when patients received everolimus with atorvastatin will change area under the time concentration curve of everolimus.

NCT ID: NCT01780831 Completed - HIV Infections Clinical Trials

Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at Risk of Acquiring HIV-1 Infection

Start date: January 28, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study was to evaluate the safety and pharmacokinetics (PK) of raltegravir (RAL) when given to HIV-1-exposed, normal birth weight newborn infants at risk of acquiring HIV-1 infection. (PK is the study of the time course of absorption, distribution, metabolism, and excretion of drugs in the body.) The primary goal of this study was to determine a dose of RAL that was safe and met the PK targets for infants when administered during the first 6 weeks of life in addition to standard of care antiretroviral (ARV) agents for prevention of perinatal transmission.

NCT ID: NCT01780753 Completed - Vivax Malaria Clinical Trials

Primaquine Pharmacokinetics in Lactating Women and Their Infants

Start date: December 2012
Phase: Phase 1
Study type: Interventional

The weight of malaria falls most heavily on young children and pregnant women but studies of the safety of antimalarials in pregnancy and lactation are few. The only recommended medication used for radical treatment of P.vivax is primaquine. The 2010 WHO malaria guidelines recommend its use in all patients with P.vivax infection in areas of low transmission, in the absence of contraindications. Primaquine is contraindicated in pregnancy. The postpartum period presents a key opportunity to definitively treat women who suffer multiple malaria relapses during pregnancy. The 2010 WHO malaria treatment guidelines allow for primaquine use during lactation but there are no studies to date quantifying primaquine excretion in breast milk and the dose that breastfed infants would be exposed to is unknown. The investigators propose to study the pharmacokinetics of primaquine in maternal and infant plasma and in breast milk during a 14 day radical treatment of P.vivax. Some inferences about the expected behavior of primaquine in lactation can be drawn from its known pharmacologic properties. Primaquine pharmacokinetics have been well characterized in healthy subjects and malaria patients after single and multiple oral dosing. Peak concentrations are reached within 2-3 hours after dosing and the plasma elimination half-life is ~7 hours. It is extensively distributed in the tissue and largely metabolized to inert carboxyprimaquine, the major plasma metabolite, which undergoes further biotransformation to unknown metabolites that are probably more toxic than the parent compound. The identification of other metabolites in humans has been difficult to pursue because the expected aminophenol metabolites are unstable. No pharmacokinetic studies have been done to measure primaquine excretion in breast milk. A few studies have been done of other antimalarials during lactation and have shown low levels of drug in breast milk during treatment.

NCT ID: NCT01780506 Completed - HIV Infections Clinical Trials

Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

Start date: December 26, 2012
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.

NCT ID: NCT01779921 Completed - Clinical trials for Congenital Bleeding Disorder

Treatment of Congenital Factor VII Deficiency

F7CONDEF
Start date: October 2005
Phase: N/A
Study type: Observational

This study is conducted globally. The aim of this study is to describe the treatment modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor VII (FVII) deficiency in addition to evaluate the presence (in already treated patients) and/or the appearance of inhibiting antibodies to FVII and/or therapy-related thrombosis. Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation Registry (STER, NCT01269138). These patients can also have been treated with other haemostatics for systemic administration.

NCT ID: NCT01778283 Completed - Clinical trials for End-stage Renal Disease

Comparison of Cardiac Index and Cardiac Output Effect During Maintenance Hemodialysis Between Acetate-Free and Acetate-Based Online Hemodiafiltration

Start date: October 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to detemine whether effect of Acetate-free solution on cardiac index and cardiac output measured by saline dilution techniques compares with Acetate-based solution in online-hemodiafiltration

NCT ID: NCT01777139 Completed - Epilepsy Clinical Trials

A Long-term, Safety, Tolerability, and Efficacy Study of Retigabine Immediate-release (IR) in Asian Adults With Partial Onset Seizures

Start date: April 11, 2013
Phase: Phase 3
Study type: Interventional

This is a multicentre, long-term, open-label extension (OLE) study to assess the long-term safety, tolerability and efficacy of retigabine immediate-release (IR) as adjunctive therapy in adult Asian subjects with drug-resistant partial-onset seizures (POS).

NCT ID: NCT01776554 Completed - Clinical trials for Pandemic H5N1 Influenza

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children

Start date: January 2013
Phase: Phase 2
Study type: Interventional

Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.

NCT ID: NCT01776541 Completed - Clinical trials for Pandemic H5N1 Influenza

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults

Start date: January 2013
Phase: Phase 2
Study type: Interventional

Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived Influenza Vaccine in Adult Subjects.