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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: NCT01764633 Completed - Dyslipidemia Clinical Trials

Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk

FOURIER
Start date: February 8, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

NCT ID: NCT01702571 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment

Start date: November 27, 2012
Phase: Phase 3
Study type: Interventional

This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.

NCT ID: NCT01592786 Completed - Autism Clinical Trials

An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Start date: June 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.

NCT ID: NCT01592747 Completed - Autism Clinical Trials

Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine

Start date: September 2012
Phase: Phase 2
Study type: Interventional

The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

NCT ID: NCT01587378 Completed - Pregnancy Clinical Trials

Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome

PregMet2
Start date: October 2012
Phase: N/A
Study type: Interventional

The overall aim of the PregMet 2 Study is to investigate whether metformin prevents late miscarriages and preterm deliveries in PCOS women treated with metformin from first trimester of pregnancy to delivery in a large, randomized, controlled, multi-centre trial setting. The investigators hypothesis is that metformin compared to placebo treatment from the first trimester to term, reduces the prevalence of late miscarriage (gestational week 13-22) and preterm birth (gestational week < 37) in PCOS women diagnosed according to Rotterdam 2003 consensus criteria, with singleton pregnancy.

NCT ID: NCT01566929 Completed - Obesity Clinical Trials

Weight Management Intervention for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF)

Start date: October 2010
Phase: N/A
Study type: Interventional

The primary aim of the study is to evaluate if weight management intervention for obese women (BMI≥30<35 kg/m2) prior to IVF improves the outcome assessed as live birth per participating woman, as compared to women where no intervention was made.

NCT ID: NCT01565239 Completed - Thromboembolism Clinical Trials

Fiix-prothrombin Time for Monitoring Warfarin

Fiix
Start date: March 2012
Phase: Phase 2
Study type: Interventional

Experiments suggest that during treatment with vitamin K antagonists (VKA) the activity of coagulation factors (F) II and X better reflect anticoagulation than does FVII. Based on this a new prothrombin time based monitoring test (Fiix-PT) has been invented which is only sensitive to FII and FX. The Fiix-PT can be converted to INR ("Fiix-INR"). The investigators hypothesize that the Fiix-PT may reflect anticoagulation and the antithrombotic effect of VKA as accurately or better than the current PT based tests do (INR based on PT or P&P). The protocol describes a prospective randomized double-blind trial that will be conducted at the Landspitali Anticoagulation Management Center (AMC). The objective of the protocol is to evaluate the efficacy and safety of Fiix-INR as a monitoring test compared to the current PT based assays (INR) used to monitor patients treated with VKA to prevent thromboembolism. The investigators will randomize 1200 clients of the AMC into two identically sized monitoring groups, Fiix-INR (test group) and INR (control group). The clinical endpoints to be studied include efficacy (arterial and venous thromboembolic event rate) and safety (bleeding events). Additionally, surrogate convenience endpoints will be studied such as test frequency and time within target range.

NCT ID: NCT01544595 Completed - Clinical trials for Moderate to Severe Plaque-type Psoriasis

Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

Start date: June 19, 2012
Phase: Phase 3
Study type: Interventional

This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.

NCT ID: NCT01468077 Completed - Clinical trials for Rheumatoid Arthritis

A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment

Start date: November 2011
Phase: Phase 2
Study type: Interventional

This multi-center, randomized, parallel-group, active-controlled, open-label study will evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion time compared to the normal infusion time. Patients will be randomized to 8 mg/kg RoActemra/Actemra infusion of 31 minutes every 4 weeks or to RoActemra/Actemra 8 mg/kg infusion of 60 minutes every 4 weeks. The anticipated time on study treatment is 24 weeks.