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All-Rac-Alpha-Tocopheryl Acetate Bp

This article discusses a clinical trial involving the use of All-Rac-Alpha-Tocopheryl Acetate BP, a form of vitamin E, as part of a multivitamin capsule for patients with Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM). The trial aims to evaluate the long-term safety and efficacy of eplontersen, an investigational drug, in ATTR-CM patients while providing vitamin supplementation, including All-Rac-Alpha-Tocopheryl Acetate BP.

Table of Contents

What is ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP?

ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP is a form of vitamin E that is used in medicinal products. It is one of the active ingredients in a medication called Concavit Capsules[1]. The term “BP” stands for British Pharmacopoeia, which is a collection of quality standards for medicines in the United Kingdom.

Vitamin E is an important nutrient that acts as an antioxidant in the body, helping to protect cells from damage caused by free radicals. It also plays a role in immune function and other metabolic processes[1].

Uses and Benefits

ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP, as part of Concavit Capsules, is used as a multivitamin supplement. Multivitamins are used to provide essential vitamins and minerals that may be missing from a person’s diet. They can help prevent or treat vitamin deficiencies[1].

The specific benefits of ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP (vitamin E) may include:

  • Supporting immune system function
  • Acting as an antioxidant to protect cells from damage
  • Supporting skin health
  • Potentially supporting heart health

However, it’s important to note that this ingredient is part of a multivitamin formulation, so its effects are combined with those of other vitamins and minerals[1].

Formulation and Administration

ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP is included in Concavit Capsules, which are soft capsules taken orally. The medication is designed for oral use, meaning it should be taken by mouth[1].

Dosage Information

While the exact dosage of ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP in Concavit Capsules is not specified in the provided information, some general dosage details for the medication are available:

  • The maximum daily dose is 3000 IU (International Units)[1].
  • The maximum total dose amount is 3,285,000 IU[1].
  • The maximum treatment period is 36 months (3 years)[1].

It’s crucial to follow the dosage instructions provided by your healthcare provider or as indicated on the product label. Do not exceed the recommended dose without consulting your doctor.

Other Ingredients in Concavit Capsules

Concavit Capsules contain several other active ingredients along with ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP. These include[1]:

  • Ergocalciferol BP (Vitamin D2)
  • Nicotinamide BP (Vitamin B3)
  • Riboflavin BP (Vitamin B2)
  • Calcium Pantothenate BP (Vitamin B5)
  • Thiamine Nitrate BP (Vitamin B1)
  • Vitamin A BP
  • Ascorbic Acid BP (Vitamin C)
  • Pyridoxine Hydrochloride BP (Vitamin B6)

This combination of vitamins makes Concavit Capsules a multivitamin supplement, classified under the ATC code A11BA for “Multivitamins, plain”[1].

Important Considerations

When taking ALL-RAC-ALPHA-TOCOPHERYL ACETATE BP as part of Concavit Capsules, keep in mind:

  • This is a prescription medication and should be taken under the guidance of a healthcare professional[1].
  • Inform your doctor about any other medications or supplements you’re taking to avoid potential interactions.
  • If you experience any unusual side effects, contact your healthcare provider immediately.
  • This medication is not specifically formulated for pediatric use[1].
  • Store the medication as directed on the packaging or by your pharmacist.

Remember, while vitamins are essential for health, more is not always better. Always follow the recommended dosage and consult with your healthcare provider if you have any concerns or questions about taking this supplement.

Aspect Details
Study Type Open-label extension study
Condition Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Main Objective Evaluate safety and tolerability of extended dosing with eplontersen
Secondary Objective Evaluate efficacy parameters in overall population and subgroups
Key Inclusion Criteria Completion of previous study or satisfactory participation in ISIS 420915CS101 study
Key Exclusion Criteria Permanent discontinuation of Study Drug in previous studies
Primary Endpoints Safety laboratory assessments, adverse events, anti-drug antibody assessments
Secondary Endpoints Biomarkers, clinical tests, imaging tests, quality of life assessments
Vitamin Supplement Concavit Capsules (including All-Rac-Alpha-Tocopheryl Acetate BP)
Maximum Treatment Period 36 months

FAQ

  • What is the purpose of this clinical trial? The main purpose of this trial is to evaluate the long-term safety and tolerability of extended dosing with eplontersen in patients with Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM). It also aims to assess the efficacy of the treatment in these patients.
  • What is All-Rac-Alpha-Tocopheryl Acetate BP? All-Rac-Alpha-Tocopheryl Acetate BP is a form of vitamin E that is included in the multivitamin capsules used in this trial. It is one of several vitamins and minerals provided to patients as part of their overall treatment plan.
  • Who is eligible to participate in this trial? Eligible participants are those who have completed the treatment period and end of treatment visit of the previous study (ION-682884-CS2) or have been diagnosed with ATTR-CM and participated satisfactorily in the ISIS 420915CS101 study. They must also be willing to adhere to vitamin A supplementation as per the protocol.
  • What tests and assessments will be performed during the trial? The trial includes various tests and assessments, such as safety laboratory assessments, clinical tests, biomarker analysis, echocardiograms, quality of life questionnaires, and physical examinations. These are designed to monitor the safety and efficacy of the treatment.
  • How long does the treatment last? The maximum treatment period mentioned in the trial information is 36 months (3 years). However, as this is an open-label extension study, the exact duration may vary for individual participants.

Ongoing Clinical Trials on All-Rac-Alpha-Tocopheryl Acetate Bp

  • Study on Long-Term Safety of Eplontersen for Adults with Transthyretin-Mediated Amyloid Cardiomyopathy

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +6

Glossary

  • ATTR-CM: Transthyretin-Mediated Amyloid Cardiomyopathy, a condition where abnormal protein deposits (amyloids) build up in the heart, affecting its function.
  • Eplontersen: An investigational drug being studied for the treatment of ATTR-CM in this clinical trial.
  • All-Rac-Alpha-Tocopheryl Acetate BP: A form of vitamin E included in the multivitamin capsules used in this study.
  • Open-label extension study: A type of clinical trial where both researchers and participants know which treatment is being administered, often following a previous study to gather long-term data.
  • Biomarkers: Measurable indicators in the body that can be used to assess the presence or progress of a disease or the effects of a treatment.
  • Echocardiogram: A test that uses sound waves to create images of the heart, allowing doctors to assess its structure and function.
  • Quality of life questionnaires: Surveys designed to measure a patient's overall well-being and how their condition affects their daily life.
  • Adverse events: Any unfavorable or unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.

References

  1. http://clinicaltrials.eu/trial/study-on-long-term-safety-of-eplontersen-for-adults-with-transthyretin-mediated-amyloid-cardiomyopathy/