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This study is designed to assess whether colesevelam given as third line treatment added to a maximal tolerated and stable dose of a statin and ezetimibe is able to further decrease the level of LDL cholesterol in a safe and efficient manner in difficult to treat Familial Hypercholesterolaemia patients who are not at their target level of LDL cholesterol.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Colesevelam hydrochloride film-coated tablets, Placebo
Service d'Endocrinologie, Metabolisme Prevention des Maladies Cardio-Vasculaires
Published on BioPortfolio: 2014-07-24T14:18:08-0400
Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT analysis of ECGs), and pharmacokinetic parameters
This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.
The objective of this study is to compare the rate and extent of absorption of paroxetine hydrochloride 40 mg film-coated tablets (test) and Paxil® (reference) administered as 1 x 40 mg f...
The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20 mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.
Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.
This is a 16-week double-blind, placebo-controlled (for colesevelam hydrochloride (HCl)) study in the type 2 diabetic subjects and pre-diabetic subjects. Diabetic participants will also b...
In the present study the feasibility of an in situ co-amorphisation of the basic drug carvedilol with the acidic co-former aspartic acid was investigated by immersion of film-coated tablets consisting...
There is a lack of information on the health care of familial hypercholesterolemia (FH).
Familial hypercholesterolemia is a genetic condition where low-density lipoprotein (LDL) receptor defects cause severe elevations of LDL cholesterol. As significant LDL-lowering effects are needed, me...
Increased epicardial fat thickness (EFT) is accepted as a risk factfcardiovascular diseases in some studies. There are conflicting results about the relation between plasma low-density lipoprotein cho...
This study was conducted to evaluate the taste and grittiness of two formulations of Riomet ER (metformin hydrochloride for extended release [ER] oral suspension 100 mg/mL) differing only in their fl...
An allylamine derivative that binds BILE ACIDS in the intestine and is used as an ANTICHOLESTEREMIC AGENT in the treatment of HYPERCHOLESTEROLEMIA and HYPERLIPIDEMIAS.
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
A film base coated with an emulsion designed for use with x-rays.
Use of a device (film badge) for measuring exposure of individuals to radiation. It is usually made of metal, plastic, or paper and loaded with one or more pieces of x-ray film.
The measurement of radiation by photography, as in x-ray film and film badge, by Geiger-Mueller tube, and by SCINTILLATION COUNTING.
Cholesterol is a waxy steroid metabolite found in the cell membranes and transported in the blood plasma. It is an important structural component of mammalian cell membranes, where it is establishes proper membrane permeability and fluidity. Cholesterol ...