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NCT ID: NCT01902264 Completed - Contraception Clinical Trials

Study of Treatment With the Combination of Drospirenone Plus Ethinyl Estradiol Plus Levomefolate Calcium in Mexican Women Seeking Contraception

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

The objective of this study is to compare the red blood cell (RBC) and plasma concentrations of folate in subjects treated with drospirenone (DRSP)/ethinyl estradiol (EE) plus levomefolate calcium (L-5-MTHF) at 24 weeks with respect to basal determination. Increased intake of folic acid (synthetic form of the naturally occurring B-vitamin) before and in the first few weeks of pregnancy has been shown to reduce certain types of birth defects. This is important for women who may become pregnant following discontinuation of oral contraception. Information about any side effects that may occur will also be collected.

NCT ID: NCT01901900 Completed - Clinical trials for Rheumatoid Arthritis

Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA.

REASSURE-E
Start date: September 2013
Phase: Phase 3
Study type: Interventional

This extension study will provide continuing treatment with secukinumab for up to 3 years for subjects who completed the phase III core study, CAIN457F2302. Subjects will be offered maintenance treatment with secukinumab at the 150 mg given subcutaneously every 4 weeks. The study aims to obtain further long term efficacy, safety and tolerability information on secukinumab for patients with rheumatoid arthritis.

NCT ID: NCT01901146 Completed - Breast Cancer Clinical Trials

Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer

Lilac
Start date: April 29, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to compare the effectiveness and safety of ABP 980 against trastuzumab in women with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

NCT ID: NCT01897532 Completed - Clinical trials for Diabetes Mellitus, Type 2

Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)

Start date: July 10, 2013
Phase: Phase 4
Study type: Interventional

The aim of the study is to investigate the longterm impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with Type 2 diabetes mellitus (T2DM) and to compare outcomes against placebo, on a background of standard of care.

NCT ID: NCT01895777 Completed - Clinical trials for Venous Thromboembolism

Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)

Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.

NCT ID: NCT01894633 Terminated - Brain Metastasis Clinical Trials

Study of Whole-brain Irradiation With Chloroquine for Brain Metastases

CLQ
Start date: May 2011
Phase: Phase 2
Study type: Interventional

Background and purposes:Chloroquine (CLQ), an antimalarial drug, has a lysosomatrophic effect associate with increase the sensibility of Radiation through leakage of hidroliticenzimes, increase of apoptosis, autophagy mediated by lysosomalhidrolases and increase of oxidative stress "in vitro". In this phase II study we evaluated the efficacy and safety as radiosensitizing of the Chloroquine plus concomitant 30 Gray (Gy) of Whole-brain irradiation (WBI)in patients with brain metastases (BM) from solid tumors.

NCT ID: NCT01894516 Completed - Clinical trials for Rheumatoid Arthritis

Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)

Start date: October 8, 2013
Phase: Phase 2
Study type: Interventional

- Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) or matching placebo for 24 weeks. - During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses of GLPG0634 administration on participants' disability, fatigue and quality of life were evaluated.

NCT ID: NCT01894022 Completed - Hypertension Clinical Trials

A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

AMBER II
Start date: January 2014
Phase: Phase 3
Study type: Interventional

This is an open label, long term extension to Study AMB115811. All subjects may remain in the extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue in the extension study until one of the following: - The product is approved locally for use in inoperable CTEPH patients; - Development for use in the CTEPH population is discontinued or product is not approved by the local regulatory authorities - The investigator decides to discontinue the subject or subject decides to discontinue from the study. The primary purpose of this study is to provide clinically relevant information on the long term safety of ambrisentan in subjects with inoperable CTEPH.

NCT ID: NCT01893450 Terminated - Clinical trials for Graves Ophthalmopathy

Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

Start date: June 2008
Phase: N/A
Study type: Interventional

Autoimmune ophthalmopathy is clinically evident in one third of Graves' disease cases. In most cases it is mild; however, in 3 to 5% of cases it has a severe presentation. At present, the treatment is directed to identify vision threatening which requires aggressive intervention, usually with glucocorticoids. For mild cases the treatment is limited to the normalization of hyperthyroidism and support measures. Preliminary data show that pentoxifylline and bromocriptine may have a favorable effect in the course of ophthalmopathy by inhibition of the synthesis of TNF-α, VEGF, glycosaminoglycan production, and lymphocyte infiltration. Therefore, the aims of this study were to evaluate the effect of bromocriptine and pentoxifylline on the clinical course and quality of life of patients with mild to moderate ophthalmopathy associated to Graves´disease. Methods. Patients with mild to moderate ophthalmopathy, with less than one year of evolution, and naive to treatment were randomized to receive treatment during 12 months with either 1) bromocriptine (5 mg twice a day) + methimazole (30 mg/day), 2) pentoxifylline (400 mg twice a day) + methimazole (30 mg/day), or 3) methimazole only (30 mg/day). They completed 10 visits to evaluate proptosis and clinical activity score (CAS). In addition, in the first and last visit the quality of life questionnaire specific for Graves' ophthalmopathy(GO-QOL) was applied.

NCT ID: NCT01892722 Recruiting - Multiple Sclerosis Clinical Trials

Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Start date: July 26, 2013
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)