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Dyslipidemia clinical trials

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NCT ID: NCT00217061 Completed - Diabetes Mellitus Clinical Trials

Effect of a Decision Aid About Statin Use in Patients With Type 2 Diabetes Mellitus

Start date: April 2005
Phase: Phase 3
Study type: Interventional

Background- Statins are a safe and effective therapy to reduce cardiovascular risk in patients with type 2 diabetes; however some patients are not prescribed statins, others do not take it even after being prescribed, and others stop therapy prematurely. Lack of knowledge or misinformation about statins may be responsible for inadequate statin use. Objective- To test the hypothesis that a formal, structured decision aid could correct deficiencies in the current decision-making process, increase statin use, and improve outcomes in patients with type 2 diabetes. Methods - The investigators will develop a decision aid called STATIN CHOICE and will pilot its efficacy in a blinded randomized controlled trial enrolling 98 type 2 diabetes patients. Outcomes- Primary outcomes: adherence to the decision to use or not to use statins three months after using STATIN CHOICE. Secondary outcomes: acceptability of STATIN CHOICE, knowledge about options, satisfaction with decisions, decisional conflict, encounter duration, and quality of life. Expected results- The investigators anticipate that this work will yield an effective and innovative decision aid for statin use in type 2 diabetes patients. STATIN CHOICE, along with a detailed users manual, will be directly applicable in clinical practice. Data and experience from this project will inform the planning and conduct of a randomized multicenter trial of the effectiveness of STATIN CHOICE in diverse practice settings. Significance- Patient participation in decision-making resulting in informed treatment decisions, as proposed in this study, will likely lead to improved quality of decision-making, more appropriate use of statins, and improved patient outcomes.

NCT ID: NCT00194402 Completed - Dyslipidemia Clinical Trials

SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers in Hyperlipidemia

Start date: August 2003
Phase: Phase 4
Study type: Interventional

Slo-Niacin and atorvastatin (Lipitor) are both drugs that lower cholesterol. In this research, we will compare the effectiveness of Slo-Niacin and atorvastatin taken alone and together. This study will help show how the individual benefits of the two drugs taken separately can be combined when taken together.

NCT ID: NCT00185705 Terminated - Hypertension Clinical Trials

Treatment of Insulin Resistance in Hypertensive, Obese Adolescents

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

In this study, we propose using telmisartan, an angiotensin II receptor antagonist with PPAR-gamma modulating activity, for a 12-week period to decrease blood pressure and insulin levels in obese, hypertensive children. Telmisartan is currently approved for treatment of adult hypertension. Recent adult studies, however, have shown telmisartan as an effective medication for lowering insulin levels and improving insulin sensitivity. We will enroll 30 obese adolescents, ages 10 to 18 years, and randomly assign half of the group to receive telmisartan and the other half to receive placebo (sugar-pill). We will obtain fasting glucose and insulin levels, as well as other markers for insulin sensitivity and cholesterol panel, at the beginning of the study, at each clinic visit in 4-week intervals, and at the end of the study. We will obtain an imaging study (computed tomography, CT scan) on 10 randomly selected study patients (5 from each group) to examine the distribution of fat tissue before and after treatment. Studies suggest that fat tissue in the subcutaneous tissue is less harmful that fat tissues surrounding internal organs, such as the liver. We will also provide nutritional handouts and exercise recommendations to each participant as a life-style intervention. Each participant will be given a diary to record his or her diet and exercise activities throughout the study.

NCT ID: NCT00171327 Completed - Hypertension Clinical Trials

Efficacy and Safety of Fluvastatin or Valsartan and Their Combination in Dyslipidemic Patients With Hypertension and Endothelial Dysfunction

Start date: July 2004
Phase: Phase 4
Study type: Interventional

Patients with mild to moderate hypertension, dyslipidemia (imbalanced blood lipids) and decreased vascular dilatation, receiving a cholesterol lowering diet were given either valsartan or fluvastatin for 8 weeks. At week 8 all patients were administered a combination treatment with valsartan 160 mg and fluvastatin 80 mg.

NCT ID: NCT00171288 Completed - Dyslipidemia Clinical Trials

Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone

Start date: August 2003
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the effect of the combination treatment on C-reactive protein and inflammatory markers as well as the safety and tolerability in a Spanish population

NCT ID: NCT00171262 Completed - Dyslipidemia Clinical Trials

Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Start date: August 2004
Phase: Phase 4
Study type: Interventional

To analyze efficacy of fluvastatin on patients with chronic renal disease by analyzing certain inflammatory markers. In addition, tolerability and safety will also be evaluated in a Spanish population.

NCT ID: NCT00169871 Completed - Dyslipidemia Clinical Trials

Hs-CRP as Clinical Marker of Inflammatory Atherogenic Dyslipidemia

Start date: March 2005
Phase: Phase 4
Study type: Observational

The objective of this proposal is to study the applicability of the hs-CRP assay in the assessment of CV risk in daily clinical conditions where hyperlipidemic population with or without CHD are currently evaluated.

NCT ID: NCT00150384 Completed - Hypertension Clinical Trials

Clinical Utility of Caduet in Achieving Blood Pressure and Lipid Endpoints in a Specific Patient Population

CAPABLE
Start date: July 2004
Phase: Phase 4
Study type: Interventional

The purpose is to demonstrate the utility of Caduet (amlodipine/atorvastatin) in the African American population

NCT ID: NCT00147797 Completed - HIV Infection Clinical Trials

Influence of Pravastatin on Carotid Artery Structure and Function in HIV-infected Patients Under Antiretroviral Therapy

Start date: May 2003
Phase: N/A
Study type: Observational

The advent of new antiretroviral agents, in particular Highly Active Antiretroviral Therapy (HAART), spectacularly reduced HIV-associated morbidity and mortality. However, new complications have appeared in HIV-infected patients treated by with HAART such as dyslipidemia, insulin resistance, diabetes mellitus, and related cardiovascular complications including acute coronary syndromes, peripheral vascular disease, and stroke have been reported. A linear association has been proved between increased intima-media thickness of the common carotid artery (CCA-IMT), aortic stiffness (pulse wave velocity [aPWV]) and incidence of cardiovascular events suggesting that IMT and aPWV could be considered as an early marker of atherosclerosis. The progression of IMT has been shown to be predictive of cardiovascular events. Case control and longitudinal studies but not all have suggested an increase CCA-IMT in HIV-infected patients under HAART compared with non-HIV infected patients with different progression. The aim of this study was to examine the effects of pravastatin on CCA-IMT and aortic stiffness in dyslipidemic HIV-infected patients receiving HAART by using a high-resolution echotracking system. Patients in the pravastatin group were consecutively recruited in four department of infectious diseases if they fulfilled the following criteria : (1) HIV-infected treated with HAART for > 12 months 2) with dyslipidemia, defined as fasting serum LDL cholesterol > 160 mg/dL before initiation of pravastatin, (3) treated with pravastatin > 12 months and one more coronary risk factor. The patients in the control group were selected consecutively in the same departments among 1) HIV-infected patients treated with HAART > 12 months 2) fasting serum LDL cholesterol > 160 mg/dL 3) without lipid-lowering drugs and one more coronary risk factor. Cases and control patients were matched for age, gender and tobacco consumption. Using data from Mercie et al., inclusion of 42 patients in pravastatin and control groups was the minimum sample size needed for detection of a 6.5% difference in CCA-IMT, in a two-sided test (a = 0.05, b = 0.20). The protocol of the study, sponsored by the French Society of Cardiology was approved by the Committee for the Protection of Human Subjects in Biomedical Research of Pitié-Salpétrière University hospital in Paris. Written informed consent to participate in the study was obtained from each patient.

NCT ID: NCT00143663 Completed - Dyslipidemia Clinical Trials

Effect of Lapaquistat Acetate on Blood Cholesterol Levels in Subjects With Elevated Cholesterol

Start date: September 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if patients with elevated cholesterol, but not taking any other lipid medication, could lower their cholesterol with administration of lapaquistat acetate, once daily (QD).