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NCT ID: NCT02002221 Completed - Clinical trials for Type 2 Diabetes Mellitus (T2DM)

Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

Start date: December 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. It was agreed with PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.

NCT ID: NCT01998958 Completed - Clinical trials for Treatment Resistant Depressive Disorder

A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression

SYNAPSE
Start date: January 27, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and dose response of intranasal esketamine (Panel A: 28 mg, 56 mg, and 84 mg and Panel B: 14 mg and 56 mg) compared with placebo in improving depressive symptoms in participants with treatment-resistant depression (TRD).

NCT ID: NCT01998776 Completed - Ulcer Hemorrhage Clinical Trials

Evaluate Misoprostol for the Healing of Small Bowel Ulcers in Low-dose Aspirin Users Complicated by Small Bowel Bleeding

Start date: April 2013
Phase: Phase 2/Phase 3
Study type: Interventional

ASA is the most commonly drug used worldwide for prevention of cardiovascular diseases. However, ASA is increasingly recognized as a culprit for small bowel bleeding. Small bowel bleeding is notoriously difficult to diagnose because it is beyond the reach of conventional endoscopy. The advent of wireless, video capsule endoscopy has revolutionized the visualization of small bowel. Capsule endoscopy is a pill that contains a tiny camera for capturing pictures of the small bowel after being swallowed. Currently, capsule endoscopy is a recommended noninvasive approach of identifying the source of small bowel bleeding. Management of ASA-associated small bowel bleeding is a major clinical challenge since there is not a single effective treatment for small bowel ulcer, and continuation of ASA increases the risk of recurrent small bowel bleeding. However, discontinuation of ASA exposes patients to thrombotic complications. Suppression of prostaglandin synthesis is an important mechanism of ASA-induced small injury. Consistent with this theory, preliminary data from a case series showed that misoprostol, a prostaglandin analog, healed small bowel ulcers in ASA users. However, the efficacy of misoprostol in healing ASA-associated small bowel ulcers has not yet been confirmed by prospective randomized trials. This double-blind clinical trial tests the hypothesis that misoprostol can heal small bowel ulcers in Aspirin users complicated by small bowel bleeding.

NCT ID: NCT01998165 Completed - Anesthesia Clinical Trials

A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised

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

The purpose of this study is to evaluate the efficacy and safety of JNJ-268229 (Ultiva /Remifentanil Hydrochloride) in pediatric participants between 1 and 15 years of age during maintenance of general anesthesia.

NCT ID: NCT01997229 Completed - Clinical trials for Refractory Generalized Myasthenia Gravis

Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)

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

The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.

NCT ID: NCT01996306 Completed - Clinical trials for Colorectal Neoplasms

A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC

AXEPT
Start date: December 2, 2013
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to determine the non-inferiority of overall survival XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.

NCT ID: NCT01995526 Completed - Healthy Volunteers Clinical Trials

A Study of Insulin Peglispro in Healthy Male Japanese Participants

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

The main purpose of this study is to evaluate how the body processes the study drug known as insulin peglispro and how the study drug affects blood sugar in healthy male Japanese participants. This study will also evaluate safety of the study drug. The study will last up to 46 days for each participant, not including screening.

NCT ID: NCT01995370 Completed - Clinical trials for Noncardioembolic Cerebral Infarction

Cilostazol Stroke Prevention Study for Antiplatelet Combination

CSPS·com
Start date: December 13, 2013
Phase: Phase 4
Study type: Interventional

To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for secondary prevention of ischemic stroke in high-risk patients for stroke

NCT ID: NCT01995136 Completed - Ocular Hypertension Clinical Trials

Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma

Start date: September 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004% ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.

NCT ID: NCT01994889 Completed - Clinical trials for Transthyretin (TTR) Amyloid Cardiomyopathy

Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

ATTR-ACT
Start date: December 9, 2013
Phase: Phase 3
Study type: Interventional

This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.