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NCT ID: NCT00439725 Completed - Clinical trials for Venous Thromboembolism

Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study

Start date: February 2007
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).

NCT ID: NCT00439647 Completed - Male Osteoporosis Clinical Trials

Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis

Start date: December 2006
Phase: Phase 3
Study type: Interventional

This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.

NCT ID: NCT00437645 Completed - Clinical trials for Essential Hypertension

Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension

Start date: January 2007
Phase: Phase 3
Study type: Interventional

This study was designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled (defined as mean sitting systolic blood pressure [msSBP] ≥ 130 mmHg and ≤ 160 mmHg) on amlodipine 5 mg alone. The study evaluated both the efficacy and tolerability of the treatments by providing data that assessed blood pressure and the proportion of patients developing peripheral edema.

NCT ID: NCT00437138 Completed - Clinical trials for Coronary Heart Disease

Controlled Exposures to Air Pollution in Patients With Coronary Heart Disease

Start date: April 2006
Phase: Phase 0
Study type: Interventional

Air pollution is a major cause of cardiovascular morbidity and mortality. The components of air pollution responsible and the mechanisms through which they might mediate these harmful effects remain only partially understood. We hypothesise that these adverse effects are mediated by combustion derived air pollutants and that even a brief exposure will effect heart and blood vessel function. We assess the effect of dilute diesel exhaust inhalation at levels encountered in urban road traffic on heart and blood vessel function in patients with stable coronary heart disease.

NCT ID: NCT00436982 Completed - Clinical trials for Arthroplasty, Replacement, Knee

Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon

Start date: February 2006
Phase: N/A
Study type: Interventional

The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.

NCT ID: NCT00436033 Completed - Clinical trials for Fibromyalgia Syndrome

A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome

Start date: February 2006
Phase: Phase 3
Study type: Interventional

Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.

NCT ID: NCT00435981 Completed - Type 1 Diabetes Clinical Trials

Efficacy and Safety of Diamyd® in Children and Adolescents With Type 1 Diabetes

Start date: January 2005
Phase: Phase 2
Study type: Interventional

This is a randomized, placebo-controlled phase II study to investigate if a prime and boost of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart, is safe and can preserve beta cell function in children and adolescents with type 1 diabetes with a diabetes duration less than 18 months at intervention.

NCT ID: NCT00435240 Completed - Clinical trials for Diabetes Mellitus, Type 2

Paleolithic Diet in the Treatment of Diabetes Type 2 in Primary Health Care

Start date: January 2005
Phase: Phase 2
Study type: Interventional

There is uncertainty about the optimal diet in the prevention and treatment of diabetes type 2. Earlier studies have generally focused on intakes of fat, protein, carbohydrate, fiber, fruit and vegetables. This study is based on another approach which compares foods that were available during human evolution with more recently introduced ones. The basic tenet from evolutionary biology is that if human physiology is less adapted to a relatively recently introduced diet based on agriculture, this could cause disturbances to human physiology and ultimately lead to diseases. Epidemiological studies indicates that diabetes mellitus type 2 is absent or near absent in populations eating a Palaeolithic ("Old Stone Age") diet which is free from food items produced in agriculture or the food industry. Our study hypothesis is that a Palaeolithic diet is better than the standard diabetes diet recommended today in treating diabetes type 2. Fifteen patients with diabetes type 2 have been randomized to 1. a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts 2. a standard diabetes diet as recommended by national health authorities. The patients eat the diet they have been randomized to for three months and then switches to the other diet for another three months. The study is conducted in Primary Health Care stations.

NCT ID: NCT00435162 Completed - Hypertension Clinical Trials

Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure

Start date: March 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure [SSBP] ≥ 95th percentile ).

NCT ID: NCT00434577 Completed - Herpes Zoster Clinical Trials

Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects

Start date: February 14, 2007
Phase: Phase 2
Study type: Interventional

Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 & 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period. No new subjects will be enrolled during the extension phases of the study.