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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR ISOPTIN


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All Clinical Trials for Isoptin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00133692 ↗ INVEST: INternational VErapamil SR Trandolapril STudy Completed Abbott Phase 4 1997-09-01 Because blood pressure affects the heart, blood vessels, kidneys, and the entire body, it is important to keep it as normal as possible. There are several different ways to control blood pressure and to prevent or limit the development of heart disease due to high blood pressure. The purpose of this study is to compare two treatments to see how well they work and the difference in their side effects. One treatment includes the use of a calcium antagonist drug (Isoptin sustained release [SR] or Verapamil SR). The other treatment excludes the calcium antagonist and may include a non-calcium antagonist drug called a beta blocker (Tenormin or Atenolol). Both treatments may also include medication called angiotensin converting enzyme (ACE) inhibitors and water pills. None of the drugs in this study are experimental, they are all approved by the Food and Drug Administration (FDA).
NCT00133692 ↗ INVEST: INternational VErapamil SR Trandolapril STudy Completed University of Florida Phase 4 1997-09-01 Because blood pressure affects the heart, blood vessels, kidneys, and the entire body, it is important to keep it as normal as possible. There are several different ways to control blood pressure and to prevent or limit the development of heart disease due to high blood pressure. The purpose of this study is to compare two treatments to see how well they work and the difference in their side effects. One treatment includes the use of a calcium antagonist drug (Isoptin sustained release [SR] or Verapamil SR). The other treatment excludes the calcium antagonist and may include a non-calcium antagonist drug called a beta blocker (Tenormin or Atenolol). Both treatments may also include medication called angiotensin converting enzyme (ACE) inhibitors and water pills. None of the drugs in this study are experimental, they are all approved by the Food and Drug Administration (FDA).
NCT00168519 ↗ Contraction (Exercise) Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes Completed Diabetes Australia N/A 2002-10-01 The purpose of this project is to determine whether glucose metabolism can be improved by administering a substance (nitric oxide donor) normally released by muscles during exercise.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Isoptin

Condition Name

Condition Name for Isoptin
Intervention Trials
Atrial Fibrillation 2
Epilepsy 1
FESS 1
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Condition MeSH

Condition MeSH for Isoptin
Intervention Trials
Atrial Fibrillation 2
Blood Loss, Surgical 1
Syndrome 1
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Clinical Trial Locations for Isoptin

Trials by Country

Trials by Country for Isoptin
Location Trials
United States 10
Canada 2
Netherlands 1
Australia 1
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Trials by US State

Trials by US State for Isoptin
Location Trials
Minnesota 2
Kentucky 1
New Hampshire 1
Illinois 1
Tennessee 1
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Clinical Trial Progress for Isoptin

Clinical Trial Phase

Clinical Trial Phase for Isoptin
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Isoptin
Clinical Trial Phase Trials
Completed 5
Not yet recruiting 3
Unknown status 1
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Clinical Trial Sponsors for Isoptin

Sponsor Name

Sponsor Name for Isoptin
Sponsor Trials
Assiut University 3
Mayo Clinic 2
Beverly S. Wical, M.D. 1
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Sponsor Type

Sponsor Type for Isoptin
Sponsor Trials
Other 18
Industry 3
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Isoptin (Verapamil): Clinical Trials, Market Analysis, and Projections

Introduction to Isoptin (Verapamil)

Isoptin, also known as verapamil, is a calcium channel blocker widely used in the treatment of hypertension, angina, and certain types of arrhythmias. Recently, it has garnered attention for its potential in treating type 1 diabetes (T1D). Here, we will delve into the latest clinical trials, market analysis, and future projections for Isoptin.

Clinical Trials: Verapamil in Type 1 Diabetes

Recent Findings

A significant clinical trial has shown promising results for verapamil in slowing the progression of type 1 diabetes in newly diagnosed children and teens. The study, which involved 88 participants, found that those treated with verapamil had a 30% improvement in C-peptide secretion at one year compared to the placebo group. This improvement indicates better preservation of pancreatic beta cell function, which is crucial for insulin production[1][4].

Study Details

  • Participant Profile: The trial included 88 participants with a mean age of 12.7 years, 41% of whom were female. The mean time from diagnosis to randomization was 24 days.
  • Outcomes: The verapamil group showed a mean C-peptide area under the curve of 0.65 pmol/mL at 52 weeks, compared to 0.44 pmol/mL in the placebo group. This difference was statistically significant, with an adjusted between-group difference of 0.14 pmol/mL[1].
  • Adherence and Safety: Drug adherence was high, with a median adherence of 94% in the verapamil group and 93% in the placebo group. The study reported few adverse events, with some participants discontinuing the drug due to presumed adverse effects[1].

Future Directions

Despite these encouraging results, verapamil is not yet approved for T1D treatment and requires further study to validate its safety and efficacy. JDRF International is funding follow-up studies to determine the long-term effects of verapamil and its potential use in conjunction with other disease-modifying therapies like Tzield™ (teplizumab-mzwv)[4].

Market Analysis: Cardiovascular Drugs Market

Current Market Size and Growth

The global cardiovascular drugs market, which includes drugs like Isoptin, was valued at USD 144.11 billion in 2023. This market is projected to grow to USD 207.78 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 4% from 2024 to 2033[5].

Key Drivers

  • Increasing Prevalence of Heart Conditions: The rise in heart-related conditions such as hypertension, coronary artery disease, and heart failure is driving the demand for cardiovascular drugs.
  • Advances in Drug Formulations: Improvements in drug formulations and the development of new therapies are contributing to market growth.
  • Aging Population: The increasing age of the global population is also a significant factor, as older individuals are more likely to suffer from cardiovascular diseases[5].

Market Segmentation

  • By Disease Indication: Hypertension is the largest segment, contributing 28.97% of the market share in 2023.
  • By Distribution Channel: Retail pharmacies hold the largest market share, accounting for 44.78% in 2023.
  • Geographical Distribution: The Asia Pacific region is growing at the fastest rate, driven by a large population base and increasing prevalence of cardiovascular diseases[5].

Market Projections for Isoptin

Potential Impact of T1D Trials

If verapamil is approved for the treatment of T1D, it could significantly expand its market reach beyond its current indications. The potential to slow the progression of T1D could make it a valuable addition to the therapeutic arsenal for this condition, potentially increasing its market share and revenue.

Competitive Landscape

The cardiovascular drugs market is highly competitive, with several major players. However, the patent cliff affecting blockbuster drugs like Xarelto, Jardiance, and Farxiga could create opportunities for mid-range transactions and the introduction of new therapies, including potential new uses for existing drugs like Isoptin[2].

Financial and M&A Activity

The improving venture capital and initial public offering (IPO) markets are expected to boost merger and acquisition (M&A) activity in the biopharma sector. Larger biopharmaceutical companies are likely to seek mid-range deals to replenish their pipelines, which could impact the market dynamics for drugs like Isoptin[2].

Safety and Efficacy Considerations

Adverse Effects and Contraindications

Verapamil is associated with several adverse effects, including hypotension, syncope, and interactions with other medications. It is contraindicated in patients with severe hepatic dysfunction and should be used cautiously in those with liver or renal impairment[3].

Dosage and Administration

The dosage of Isoptin SR (verapamil hydrochloride) must be carefully adjusted, especially in patients receiving diuretics or ACE inhibitors, as additive antihypertensive effects can occur. Patients with attenuated neuromuscular transmission, such as those with Duchenne’s muscular dystrophy, may require dose adjustments[3].

Key Takeaways

  • Clinical Trials: Verapamil has shown promise in preserving beta cell function in newly diagnosed T1D patients, but further studies are needed.
  • Market Growth: The global cardiovascular drugs market is expected to grow to USD 207.78 billion by 2033, driven by increasing prevalence of heart conditions and advances in drug formulations.
  • Market Potential: Approval for T1D treatment could expand Isoptin's market reach and revenue.
  • Safety and Efficacy: Careful dosage adjustment and monitoring are necessary due to potential adverse effects and interactions.

FAQs

Q: What is the current status of verapamil in treating type 1 diabetes?

A: Verapamil has shown promising results in clinical trials for preserving beta cell function in newly diagnosed T1D patients but is not yet approved for this indication.

Q: How does verapamil affect C-peptide levels in T1D patients?

A: Verapamil has been shown to improve C-peptide secretion by 30% at one year compared to placebo, indicating better preservation of pancreatic beta cell function.

Q: What are the potential side effects of verapamil?

A: Verapamil can cause hypotension, syncope, and interact with other medications. It should be used cautiously in patients with liver or renal impairment.

Q: How is the global cardiovascular drugs market expected to grow?

A: The market is projected to grow from USD 144.11 billion in 2023 to USD 207.78 billion by 2033, with a CAGR of 4%.

Q: What regions are driving the growth in the cardiovascular drugs market?

A: The Asia Pacific region is growing at the fastest rate due to a large population base and increasing prevalence of cardiovascular diseases.

Sources

  1. JAMA Network: "Effect of Verapamil on Pancreatic Beta Cell Function in Newly Diagnosed Type 1 Diabetes: A Randomized Clinical Trial"[1].
  2. GEN News: "Seven Biopharma Trends to Watch in 2025"[2].
  3. Health Canada: "ISOPTIN® SR (verapamil hydrochloride) Product Monograph"[3].
  4. Breakthrough T1D: "Exciting news: new drug in clinical trials shows slowed type 1 diabetes progression in newly diagnosed children and teens"[4].
  5. BioSpace: "Cardiovascular Drugs Market Size to Worth USD 207.78 billion by 2033"[5].

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