Active clinical trials for "Hyperlipidemias"

Funding Source - FDA OOPD This study is being done to find out whether an investigational (not approved by FDA ) drug called SLx-4090 or Orlistat (FDA approved medication for weight loss) when given alone or in combination can treat the high blood fat (elevated triglycerides)levels found in the condition Type 1 Hyperlipoproteinemia (T1HLP) better or more safely than low fat diet alone, the current standard medical care. It is also not clear whether Orlistat, that is FDA approved for weight loss, is effective in lowering blood fat levels in patients with Type 1 hyperlipoproteinemia (T1HLP). The researchers are interested in learning whether any one of these drugs when given alone or in combination is more effective and safe in treating T1HLP.

Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels.

The Torcetrapib project was terminated on December 2, 2006 due to safety findings. Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of combination cholesterol medications to see how the different treatments compare to one another.

The Torcetrapib project was terminated on December 2, 2006 due to safety findings. Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

Despite undeniable progress in the reduction of morbidity and mortality of coronary heart disease (CHD) prevention is a mainstay for medical intervention. The importance of elevated serum cholesterol for the formation and progress of CHD can be regarded as proved after the results of the major intervention studies became available. These studies have provided key evidence for a positive correlation of lipid lowering and decreased mortality. Other studies in patients with established CHD have shown that stabilization and regression of atherosclerotic lesions is possible with lowering of cholesterol using a variety of agents. Different studies have also investigated the long-term effects of lipid lowering strategies on atherosclerosis by means of coronary angiography and have demonstrated that lipid reduction reduces progression of atherosclerosis and can promote atherosclerosis regression. Thus, it has been demonstrated that cholesterol lowering therapy reduces the risk of CHD and diminishes cardiovascular morbidity and mortality. Policosanol is a drug that presumably possesses both hypocholesterolemic and antiplatelet effects. Furthermore there are hints to even more positive effects that influence the development of atherosclerosis, i.e. inhibition of LDL peroxidation and smooth muscle cell proliferation. Previous studies showed efficacy in dose ranges of mostly 5 to 20 mg Policosanol per day. As nearly all previous studies have been performed in Latin America it cannot be excluded that either ethnic or nutritional factors contribute to the dose found to be optimal in this region. This circumstance as well as the requirement to meet the ICH Guideline "Ethnic Factors in the Acceptability of Foreign Clinical Data" make further studies, i.e. a dose-finding clinical trial, an efficacy clinical trial in European patients and a long-term tolerability clinical trial in Caucasian patients necessary. It is known from more than 60 clinical studies performed so far that Policosanol has an excellent safety profile. A placebo-controlled design was considered appropriate as patients with two or more risk factors for the development of cardiovascular events and a LDL of greater than 190 mg/dl were excluded; the chance of getting an active lipid-lowering agent during the treatment phase was 80 %.

This study will evaluate the safety and effect of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) when added to ongoing lipid-lowering therapy. The primary hypothesis is that treatment with anacetrapib 100 mg for 12 weeks will lower LDL-C to a greater extent than treatment with placebo.

Lipoprotein lipase deficiency (LPLD) is a rare autosomal recessive disorder, characterized by loss-of function mutations in the LPL gene, leading to the inability to produce functionally active lipoprotein lipase (LPL). LPL is the key enzyme in the metabolism of triglyceride (TG)-rich lipoproteins (chylomicrons (CM) and very low-density lipoproteins (VLDL)). LPLD results in extremely high concentrations of circulating TG-rich lipoproteins. No drug therapy for LPLD is currently available. Clinical management of LPLD patients consists of severe dietary fat restriction and the use of medium-chain triglycerides to substitute for normal dietary fats. Alipogene tiparvovec (Glybera®) received marketing authorisation from the European commission on 25 October 2012. Glybera® aims to correct lipoprotein lipase deficiency sufficiently to decrease the morbidity and lower the risk of inherent complications of LPLD, in adult patients genetically diagnosed with LPLD. The Glybera Registry is designed to collect the long-term safety and efficacy data of GLYBERA®

The design of the study will be randomized, double blind trial, which will examine the effects of Rosiglitazone on the fasting triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and plasma concentrations of apolipoproteins A-I, A-II, and C-III as compared to Fenofibrate and placebo. This study will also assess the synergistic effect of Rosiglitazone and Fenofibrate on the same parameters. Data from this study will help clarify whether Rosiglitazone favorably impacts plasma lipid and lipoprotein concentrations through improving insulin sensitivity and glycemic control, or by directly influencing the synthesis of the apolipoproteins that are responsible for very-low-density lipoprotein (VLDL) and HDL metabolism.

The primary purpose of this study is to test the effectiveness and tolerability of Niaspan® to improve the levels of blood fats ("good" and "bad" cholesterol and triglyceride levels) in people who have kidney damage due to diabetes. A secondary goal is to test whether Niaspan® slows down further development of kidney damage.

This pilot study consists of a pair of pragmatic clinical trials that will evaluate two separate methods for optimizing referral of eligible patients to a centralized pharmacy service for statin management: 1) A stepped wedge clinical trial, with randomization at the level of the provider, evaluating a visit-based nudge for referral to pharmacy services versus usual care; 2) A cluster randomized trial, with randomization at the level of the practice, evaluating a non-visit based nudge for referral to pharmacy services versus usual care.