CLINICAL TRIALS PROFILE FOR PARACORT

505(b)(2) Clinical Trials for Paracort

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT03742258 ↗	Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2019-03-13	The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
OTC	NCT03742258 ↗	Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma	Active, not recruiting	Northwestern University	Phase 1	2019-03-13	The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.

All Clinical Trials for Paracort

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00025259 ↗	Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease	Completed	National Cancer Institute (NCI)	Phase 3	2002-09-01	This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
NCT00025259 ↗	Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease	Completed	Children's Oncology Group	Phase 3	2002-09-01	This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	Children's Oncology Group	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00390793 ↗	Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.	Active, not recruiting	Bristol-Myers Squibb	Phase 2	2006-09-28	This phase II trial studies how well combination chemotherapy and dasatinib works in treating participants with Philadelphia-positive or B-cell receptor-ABL positive acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy in combination with dasatinib may work better in treating participants with Philadelphia-positive or BCR-ABL positive acute lymphoblastic leukemia.
NCT00390793 ↗	Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2006-09-28	This phase II trial studies how well combination chemotherapy and dasatinib works in treating participants with Philadelphia-positive or B-cell receptor-ABL positive acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy in combination with dasatinib may work better in treating participants with Philadelphia-positive or BCR-ABL positive acute lymphoblastic leukemia.

Clinical Trial Conditions for Paracort

Condition Name

Condition Name for Paracort
Intervention	Trials
Acute Lymphoblastic Leukemia	14
B Acute Lymphoblastic Leukemia	9
Untreated Adult Acute Lymphoblastic Leukemia	9
Leukemia	9

Condition MeSH

Condition MeSH for Paracort
Intervention	Trials
Lymphoma	38
Leukemia	33
Precursor Cell Lymphoblastic Leukemia-Lymphoma	32
Leukemia, Lymphoid	32

Clinical Trial Locations for Paracort

Trials by Country

Trials by Country for Paracort
Location	Trials
Canada	74
Australia	28
New Zealand	13
Puerto Rico	7
Israel	4

Trials by US State

Trials by US State for Paracort
Location	Trials
Texas	51
California	38
Washington	37
Illinois	34
Ohio	34

Clinical Trial Progress for Paracort

Clinical Trial Phase

Clinical Trial Phase for Paracort
Clinical Trial Phase	Trials
Phase 3	17
Phase 2/Phase 3	3
Phase 2	47

Clinical Trial Status

Clinical Trial Status for Paracort
Clinical Trial Phase	Trials
Recruiting	37
Active, not recruiting	23
Not yet recruiting	13

Clinical Trial Sponsors for Paracort

Sponsor Name

Sponsor Name for Paracort
Sponsor	Trials
National Cancer Institute (NCI)	77
M.D. Anderson Cancer Center	24
University of Washington	8

Sponsor Type

Sponsor Type for Paracort
Sponsor	Trials
Other	85
NIH	78
Industry	30

Clinical Trials Update, Market Analysis, and Projections for Sacubitril/Valsartan (Paracor)

Introduction

Sacubitril/valsartan, often referred to by its brand name Entresto, is a combination drug used primarily for the treatment of heart failure. Recently, it has been the subject of clinical trials to explore its efficacy in patients who have recovered from COVID-19. Here, we will delve into the latest clinical trial updates, market analysis, and projections for this drug.

Clinical Trial Overview: PARACOR-19

The PARACOR-19 randomized controlled trial (RCT) is a significant study that aimed to investigate the effects of sacubitril/valsartan on patients who had recovered from acute COVID-19 infection. Here are the key points from this trial:

Design and Participants

• The trial was a single-center, double-blind RCT involving patients with cardiovascular risk factors and a history of COVID-19 infection 4-16 weeks prior to enrollment.
• A total of 42 patients were randomized, with 20 receiving sacubitril/valsartan and 22 receiving a placebo[1].

Dosage and Endpoints

• Patients were titrated to the maximum dose of 97/103 mg of sacubitril/valsartan twice daily.
• The co-primary endpoints were changes from baseline to 12 weeks in high-sensitivity cardiac troponin T (hs-cTnT) and soluble ST2 (sST2)[1].

Results

• The trial found that sacubitril/valsartan did not have a significant effect on the co-primary endpoints of hs-cTnT and sST2 compared to the placebo group.
• However, exploratory analyses suggested potential benefits of sacubitril/valsartan on cardiac wall stress and collagen turnover, as measured by N-terminal pro-B-type natriuretic peptide (NT-proBNP) and C-terminal telopeptide of collagen type I (CITP)[1].

Safety and Tolerability

• The drug was well tolerated, with permanent drug discontinuation occurring in four patients in the sacubitril/valsartan group and three patients in the placebo group. There were no deaths, and one patient was hospitalized in each group[1].

Market Analysis

Current Market Size and Growth

The market for cardiovascular drugs, including sacubitril/valsartan, has seen significant growth, particularly driven by the COVID-19 pandemic. Here are some key market insights:

Global Cardiovascular Drug Market

• The global cardiovascular drug market is part of a larger pharmaceutical market that has been growing steadily. The COVID-19 pandemic accelerated this growth due to increased focus on novel drug development and clinical trials[3].

Specific Market for Sacubitril/Valsartan

• While specific market size data for sacubitril/valsartan is not readily available, the drug's approval and use in treating heart failure contribute to its market presence. The success of sacubitril/valsartan in reducing hospitalization and mortality in heart failure patients has established it as a key player in the cardiovascular drug market.

Market Projections

Growth Drivers

Several factors are expected to drive the growth of the market for sacubitril/valsartan and similar cardiovascular drugs:

Technological Advancements

• Rapid technological evolution, including advancements in drug delivery systems and personalized medicine, is expected to positively impact the market[3].

Increasing Prevalence of Chronic Diseases

• The rising prevalence of chronic diseases such as heart failure and hypertension will continue to drive demand for effective treatments like sacubitril/valsartan.

Globalization of Clinical Trials

• The globalization of clinical trials, facilitated by collaborations between pharmaceutical companies and contract research organizations (CROs), will further expand the market reach of sacubitril/valsartan[3].

Market Forecast

• The global clinical trials market, which includes trials for cardiovascular drugs like sacubitril/valsartan, is projected to grow at a CAGR of 6.49% from 2024 to 2030. This growth is expected to be driven by the factors mentioned above[3].

Competitive Landscape

The market for cardiovascular drugs is highly competitive, with several key players:

Major Players

• Companies like Novartis, the manufacturer of Entresto (sacubitril/valsartan), are major players in this market. Other companies involved in cardiovascular drug development also contribute to the competitive landscape.

Market Share

• The market share of sacubitril/valsartan within the cardiovascular drug market is significant due to its efficacy and approval for treating heart failure.

Regulatory Environment

FDA Approvals and Guidelines

• The FDA plays a crucial role in regulating clinical trials and drug approvals. For sacubitril/valsartan, the FDA has approved its use for heart failure, and any future approvals for additional indications, such as post-COVID-19 care, would significantly impact its market[4].

Conclusion

The PARACOR-19 trial provides valuable insights into the potential benefits of sacubitril/valsartan for patients who have recovered from COVID-19, despite not meeting its primary endpoints. The market for this drug is expected to grow driven by technological advancements, the increasing prevalence of chronic diseases, and the globalization of clinical trials.

Key Takeaways

• Clinical Trial Insights: Sacubitril/valsartan did not lower hs-cTnT or sST2 but showed potential benefits in reducing cardiac wall stress and collagen turnover.
• Market Growth: The global clinical trials market, including cardiovascular drugs, is projected to grow at a CAGR of 6.49% from 2024 to 2030.
• Competitive Landscape: Novartis and other pharmaceutical companies are key players in the cardiovascular drug market.
• Regulatory Environment: FDA approvals and guidelines are crucial for the expansion of sacubitril/valsartan's market.

FAQs

What was the primary objective of the PARACOR-19 clinical trial?

The primary objective of the PARACOR-19 trial was to examine the effects of sacubitril/valsartan on markers of cardiac injury, inflammation, structure, and function in patients who had recovered from acute COVID-19 infection.

What were the co-primary endpoints of the PARACOR-19 trial?

The co-primary endpoints were changes from baseline to 12 weeks in high-sensitivity cardiac troponin T (hs-cTnT) and soluble ST2 (sST2).

Did sacubitril/valsartan meet its primary endpoints in the PARACOR-19 trial?

No, sacubitril/valsartan did not have a significant effect on the co-primary endpoints of hs-cTnT and sST2 compared to the placebo group.

What potential benefits were observed in the exploratory analyses of the PARACOR-19 trial?

Exploratory analyses suggested potential benefits of sacubitril/valsartan on cardiac wall stress and collagen turnover, as measured by NT-proBNP and CITP.

What is the projected growth rate of the global clinical trials market from 2024 to 2030?

The global clinical trials market is projected to grow at a CAGR of 6.49% from 2024 to 2030.

Sources

1. The PARACOR-19 randomized clinical trial - PubMed
2. Global Paracord Bracelet Market Trends Analysis, Growth, Size - Market.biz
3. Clinical Trials Market Size, Share And Growth Report, 2030 - Grand View Research
4. Drug Trials Snapshots - FDA
5. Paracord Bracelet Market Size, Share, Growth | Global Report, 2030 - Verified Market Reports

Last updated: 2025-01-07