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NCT ID: NCT01989754 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus

CANVAS-R
Start date: January 16, 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.

NCT ID: NCT01989468 Completed - Psoriatic Arthritis Clinical Trials

24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis

Start date: April 10, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.

NCT ID: NCT01989208 Completed - Heart Failure Clinical Trials

Assessing the Safety and Ability of SG1002 to Overcome Deficits in Hydrogen Sulfide in Heart Failure Patients

Start date: January 2014
Phase: N/A
Study type: Interventional

Patients with heart failure are reported to have lower levels of hydrogen sulfide in their blood, even though sulfur is available naturally in the diet. Hydrogen sulfide is a molecule that has been shown to have a number of beneficial effects and thus the low levels may contribute to the disease. This trial is testing whether a medical food product of synthetic sulfur molecules, SG1002, can overcome this deficit in blood levels of hydrogen sulfide.

NCT ID: NCT01988896 Completed - Solid Tumors Clinical Trials

Study of Atezolizumab in Combination With Cobimetinib in Participants With Locally Advanced or Metastatic Solid Tumors

Start date: December 27, 2013
Phase: Phase 1
Study type: Interventional

This is a Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and pharmacokinetics of coadministration of intravenous (IV) dosing of atezolizumab (an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody) and oral dosing of cobimetinib in participants with metastatic or locally advanced cancer for which no standard therapy exists.

NCT ID: NCT01987921 Completed - Acute Kidney Injury Clinical Trials

Observational Study of Pediatric Acute Kidney Injury, Risk Factors and Outcomes

AWARE
Start date: January 2014
Phase: N/A
Study type: Observational [Patient Registry]

Pediatric acute kidney injury (AKI) is associated with increased morbidity and mortality in critically ill patients. Currently, understanding of the epidemiology and diagnosis of AKI in children is limited by single center retrospective data and inconsistent diagnostic and stratification criteria. The hypotheses of the AWARE study is that 1) renal angina, a composite of early injury signs and risk of disease, will predict severe subsequent AKI in critically ill children and 2) the incorporation of urinary biomarkers into the renal angina scoring system will improve the prediction of the severe injury. The AWARE study is conducted to describe AKI epidemiology in a heterogeneous multinational cohort of critically ill children, characterize AKI risk factors and associated morbidity, and validate the KDIGO AKI criteria as a predictor of pediatric AKI outcomes. The multi-center, multi-national registry will create the largest ever repository of information available on AKI in children.

NCT ID: NCT01987895 Completed - Clinical trials for Clostridium Difficile Infection

Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea

Start date: March 27, 2014
Phase: Phase 3
Study type: Interventional

This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

NCT ID: NCT01987492 Completed - Asthma Clinical Trials

A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma

Start date: February 28, 2014
Phase: Phase 2
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.

NCT ID: NCT01987453 Completed - HCV Infection Clinical Trials

Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

Start date: July 2014
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).

NCT ID: NCT01985230 Completed - Clinical trials for Chronic Low Back Pain

ReActiv8 for Chronic Low Back Pain (PMCF)

ReActiv8-A
Start date: February 2014
Phase: N/A
Study type: Interventional

The purpose of this Clinical Study is to investigate the effect of electrical stimulation for chronic low back pain.

NCT ID: NCT01984801 Completed - Acne Vulgaris Clinical Trials

Study to Investigate the Irritation Potential of GSK1940029 Gel

Start date: October 14, 2013
Phase: Phase 1
Study type: Interventional

The proposed indication for GSK1940029 is topical treatment of acne, the early clinical plan will evaluate the irritation potential of GSK1940029 (Study SCD117225 - 3 Part study); and safety, tolerability and pharmacokinetics of GSK1940029 (Study SCD117226 - 2 Part study), after topical administration on healthy subjects and acne patients. Study SCD117225 will be a randomized, single-blind, three part study, to evaluate the primary irritation potential (Part 1), cumulative irritation potential (Part 2) of two concentrations of GSK1940029 gel applied to the intact skin of healthy subjects, and the facial irritation potential of one or two concentrations of GSK1940029 applied to the face of acne patients (Part3). In Part 1 and Part 2 the following 6 treatments will be applied using individual patches: (A) 200 milligrams (mg) of 0.3% GSK1940029 gel, (B) 200 mg of 1% GSK1940029 gel, (C) 200 mg of 0.3%/1% vehicle gel only (vehicle control), (D) 200 microliters (µL) of sterile distilled water (negative irritant control), (E) 200 µL of - 0.5% sodium lauryl sulfate (SLS) in sterile distilled water for Part 1/0.1% SLS in sterile distilled water for Part 2 (positive irritant control), and (F) Patch only (patch control). Each treatment will be randomized to one of six designated locations on either upper arm or other locations, such as the lower or upper back, within each subject. The same treatment will be reapplied to the same location on subsequent days. Each treatment will be applied daily for 2 days in Part 1, and daily for 21 days in Part 2. In Part 3, each patient will apply a thin coat of one or two concentration of GSK1940029 gel or vehicle to acne affected facial/neck skin by hand, once daily for 28 days. Parts within Study SCD117225 and Study SCD117226 will have interdependencies. No significant primary irritation signal in Study SCD117225 Part 1 would allow initiation of Study SCD117226 Part 1 (single dose application). Once safety, tolerability and exposure information are determined in Study SCD117226 Part 1, Part 2 of Study SCD117225 may be initiated along with Part 2 (14-day repeat dose application). No significant cumulative irritation signal (study SCD117225 Part 2) in combination with adequate 14-day safety (study SCD117226 Part 2) would allow initiation of Part 3 of Study SCD117225.