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NCT ID: NCT01035255 Completed - Clinical trials for Heart Failure With Reduced Ejection Fraction

This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure

PARADIGM-HF
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).

NCT ID: NCT01035164 Completed - Alzheimer's Disease Clinical Trials

Evaluation of ZK 6032924 in Probable Alzheimer's Disease Patients Versus Healthy Volunteers and the Radiation Dosimetry of ZK 6032924 in Healthy Volunteers

Start date: June 2007
Phase: Phase 1
Study type: Interventional

PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.

NCT ID: NCT01035138 Completed - Alzheimer's Disease Clinical Trials

A Study of Semagacestat for Alzheimer's Patients

Identity XT
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The primary objective of the original study was to assess the safety of semagacestat in Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0 of this study (LFBF). Preliminary results from LFAN and LFBC showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC and LFBF have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol. Very few participants from LFBC rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC participants who rolled into LFBF were not analyzed.

NCT ID: NCT01034995 Completed - Major Depression Clinical Trials

A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder

AGATE
Start date: February 2010
Phase: Phase 2
Study type: Interventional

Primary Objective: - To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score. Secondary Objectives: - To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder - To evaluate plasma concentrations of SSR125543

NCT ID: NCT01034943 Completed - Clinical trials for Dorsally Displaced Intraarticular Distal Radius Fractures

Extraarticular Distal Radius Fractures, X-fix or Volar Fixation

Start date: August 2009
Phase: N/A
Study type: Interventional

Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.

NCT ID: NCT01033994 Completed - Knee Osteoarthritis Clinical Trials

A Multicenter Study of rhFGF 18 in Patients With Knee Osteoarthritis Not Requiring Surgery

Start date: October 2008
Phase: Phase 1
Study type: Interventional

Osteoarthritis (OA) is one of the most common diseases affecting the joints, usually those that are weight bearing such as the knees. OA is considered to be a disease of the cartilage in the joints even though it involves the whole joint, including the bone and synovium (thin lining of the joints which produces synovial fluid). With time, more and more of the cartilage is destroyed by the disease with inflammation commonly occurring. AS902330 is expected to increase the production and development of specific bone cells: chondrocytes and osteoblasts (cells that produce and maintain bone and cartilage). This is expected to lead to repair and generation of the cartilage, and a narrowing of the space width between the knee joints in a selected region of the knee cartilage. The purpose of this study is to see how safe treatment with AS902330 is, and to evaluate its effect on the knee cartilage. In addition, the study will also measure the effects of AS902330 in the blood, which reflect disease activity.

NCT ID: NCT01033903 Completed - Clinical trials for Abortion, Spontaneous

Optimal Treatment of Miscarriage

Start date: October 1, 2008
Phase: N/A
Study type: Interventional

The main objective of the study is to determine if there is a difference in the number of women with a complete miscarriage after 10 days between expectant management versus treatment with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus.

NCT ID: NCT01033656 Completed - Clinical trials for Adult-Onset Still's Disease

Treatment of Refractory Adult-onset Still's Disease With Anakinra: a Randomized Study

NordicAOSD05
Start date: December 2005
Phase: Phase 2
Study type: Interventional

An open, randomized, parallel-group, comparative, multicentre study. Patients on corticosteroids (plus conventional therapy) will be randomized to receive anakinra (Kineret®), or one of the following: methotrexate, azathioprine, leflunomide, cyclosporin A or sulphasalazine. Patients enter the study if considered refractory to corticosteroids (prednisolone equivalent ≥10 mg/day) at the time of randomization. The randomized phase of the study will be followed by an open-label extension (OLE) phase, to follow-up drug survival, efficacy, tolerability and disease-related parameters of long-term treatment with anakinra or one of the study DMARDs or a combination of study drugs for additional 28 weeks.

NCT ID: NCT01033539 Completed - Clinical trials for The Safety of Lactobacillus Reuteri ATCC PTA 4659

To Demonstrate That Lactobacillus Reuteri ATCC PTA 4659 Survives Passage Through the Gastrointestinal Tract of Humans

Start date: November 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effects of a sachet containing Lactobacillus Reuteri ATCC PTA 4659 on the recovery of live Lactobacillus reuteri in fecal samples after 7, 14 and 28 days supplementation as well as 14 days wash out compared to the same sachet without the probiotic bacteria as placebo control.

NCT ID: NCT01032629 Completed - Clinical trials for Diabetes Mellitus, Type 2

CANVAS - CANagliflozin cardioVascular Assessment Study

CANVAS
Start date: December 9, 2009
Phase: Phase 3
Study type: Interventional

The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin. The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.