CLINICAL TRIALS PROFILE FOR RAMIPRIL

All Clinical Trials for Ramipril

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005928 ↗	Effects of Angiotensin-Converting Enzyme Inhibitor (Ramipril) Therapy on Blood Vessel Inflammation	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2000-06-01	This study will determine the effects of angiotensin-converting enzyme (ACE) inhibitor (trade name Ramipril) therapy on inflammation and stiffness of artery walls. These are two risk factors for developing atherosclerosis-deposits of fatty substances called plaques that can block the blood vessel, causing a heart attack or stroke. Studies of patients with coronary artery disease suggest that ACE inhibitor therapy reduces the risk of heart attack and heart failure. This study will examine the effects of this treatment on the artery walls and on levels of substances in the blood that indicate blood vessel inflammation. Patients between 40 and 75 years old with coronary artery disease caused by atherosclerosis may be eligible for this study. Candidates will be screened with a medical history, cardiovascular (heart and blood vessel) examination, electrocardiogram and blood tests. Those enrolled will be randomly assigned to take either an ACE inhibitor pill or a placebo (look-alike pill with no medicine) once a day for 3 months. No pills will be taken for the next month, and then participants will take the alternate pill for the next 3 months. That is, those who took ACE inhibitor for the first 3-month period will take placebo for the second 3-month period and vice versa. Blood pressures will be taken at the NIH Clinical Center or by the patient's physician at the end of the first and second weeks of the study. At the end of 3 weeks, patients will return to the Clinical Center for a blood draw of 6 cc (1/2 teaspoon) to assess kidney function. In addition, at the end of each 3-month study period, patients will undergo the following procedures at the Clinical Center: 1. Fasting blood draw of 60 cc (2 ounces) to measure electrolytes (e.g., sodium and potassium) and blood markers for inflammation 2. Ultrasound (use of sound waves to create pictures) study of the carotid arteries (arteries in the neck leading to the brain)-An ultrasound probe is applied gently on the neck, and ultrasound pictures of the right and left carotid arteries are recorded on tape. Heart activity and blood pressure are monitored during the procedure with an electrocardiogram and blood pressure cuff. 3. Magnetic resonance imaging (MRI) of the carotid arteries-The patient lies on a table in a narrow cylinder (the MRI machine) containing a magnetic field. A flexible padded sensor called a MRI coil is placed over the neck area. Earplugs are placed in the ear to muffle the loud thumping sounds the machine makes when the magnetic fields are switched. During the second half of the exam, a contrast agent (gadolinium) is injected through an intravenous catheter (flexible tube placed in a vein) to brighten the images. The heart is monitored during the procedure with an electrocardiogram.
NCT00044265 ↗	Treatment of Pediatric Hypertension With Altace Trial	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 4	2002-07-01	Ramipril is an ACE inhibitor that has been marketed in the US for the treatment of hypertension since 1991. It has been shown to be effective in reducing both systolic and diastolic blood pressure in adults when used once daily. ACE inhibitors are frequently used to treat hypertension in children, however ramipril has not been extensively tested in children, and information regarding the efficacy and safety would therefore be of benefit to children. This study is designed to demonstrate the efficacy and safety of ramipril in the treatment of hypertension in children ages 6 through 16 years.
NCT00044265 ↗	Treatment of Pediatric Hypertension With Altace Trial	Completed	Pfizer	Phase 4	2002-07-01	Ramipril is an ACE inhibitor that has been marketed in the US for the treatment of hypertension since 1991. It has been shown to be effective in reducing both systolic and diastolic blood pressure in adults when used once daily. ACE inhibitors are frequently used to treat hypertension in children, however ramipril has not been extensively tested in children, and information regarding the efficacy and safety would therefore be of benefit to children. This study is designed to demonstrate the efficacy and safety of ramipril in the treatment of hypertension in children ages 6 through 16 years.
NCT00054938 ↗	Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2	2003-03-01	The purpose of this study is to find the best way to prevent heart disease and stroke in people with lupus (systemic lupus erythematosis, or SLE). The study will evaluate the effectiveness of medication and a phone-based education program in controlling four risk factors for heart disease: smoking, obesity, high blood pressure, and inactivity. The study will also test the safety of commonly used heart medications in people with lupus.
NCT00054938 ↗	Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)	Completed	Brigham and Women's Hospital	Phase 2	2003-03-01	The purpose of this study is to find the best way to prevent heart disease and stroke in people with lupus (systemic lupus erythematosis, or SLE). The study will evaluate the effectiveness of medication and a phone-based education program in controlling four risk factors for heart disease: smoking, obesity, high blood pressure, and inactivity. The study will also test the safety of commonly used heart medications in people with lupus.

Clinical Trial Conditions for Ramipril

Condition Name

Condition Name for Ramipril
Intervention	Trials
Hypertension	48
Healthy	17
Diabetic Nephropathy	8
Diabetes	7

Condition MeSH

Condition MeSH for Ramipril
Intervention	Trials
Hypertension	58
Kidney Diseases	19
Diabetes Mellitus	17
Renal Insufficiency, Chronic	10

Clinical Trial Locations for Ramipril

Trials by Country

Trials by Country for Ramipril
Location	Trials
United States	302
Canada	53
Italy	46
Spain	32
Germany	30

Trials by US State

Trials by US State for Ramipril
Location	Trials
Texas	18
California	17
New York	13
Illinois	13
Florida	12

Clinical Trial Progress for Ramipril

Clinical Trial Phase

Clinical Trial Phase for Ramipril
Clinical Trial Phase	Trials
Phase 4	60
Phase 3	41
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Ramipril
Clinical Trial Phase	Trials
Completed	115
Terminated	15
Unknown status	14

Clinical Trial Sponsors for Ramipril

Sponsor Name

Sponsor Name for Ramipril
Sponsor	Trials
Boehringer Ingelheim	12
Sanofi	11
Novartis	9

Sponsor Type

Sponsor Type for Ramipril
Sponsor	Trials
Other	157
Industry	96
NIH	12

Ramipril: Clinical Trials, Market Analysis, and Projections

Introduction to Ramipril

Ramipril is an angiotensin-converting enzyme (ACE) inhibitor, widely used to treat high blood pressure, heart failure, and to prevent cardiovascular events such as myocardial infarction and stroke. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

RAMIC Trial: Ramipril for COVID-19 Treatment

A recent clinical trial, the RAMIC trial, investigated the efficacy of de novo ramipril treatment for COVID-19. This randomized, multicenter, placebo-controlled, double-blind trial involved 114 participants with confirmed SARS-CoV-2 infection. The results showed that ramipril did not significantly improve or worsen clinical outcomes compared to placebo, but it appeared safe for non-critically ill patients with COVID-19. The primary endpoint of mortality, ICU admission, or invasive mechanical ventilation by day 14 did not differ significantly between the ramipril and placebo groups[1].

Heart Outcomes Prevention Evaluation (HOPE) Study

The HOPE study is a landmark trial that evaluated the effectiveness of ramipril in preventing myocardial infarction, stroke, or cardiovascular death in patients at high risk for cardiovascular events. The study found that ramipril significantly reduced the risk of these outcomes compared to placebo. Specifically, the ramipril group had lower rates of cardiovascular death, myocardial infarction, and stroke. This study underscored the benefits of ramipril in managing cardiovascular health[4].

Market Analysis

Current Market Size and Growth

The global ramipril market has been growing steadily, driven by the increasing prevalence of hypertension and cardiovascular diseases. As of 2021, the market was valued at USD 550 million and is projected to reach USD 729.86 million by 2029, growing at a CAGR of 3.6% during the forecast period[3].

Market Drivers

Several factors are driving the growth of the ramipril market:

• Rising Prevalence of Cardiovascular Diseases: The increasing incidence of high blood pressure, hypertension, and other heart-related conditions is a key driver.
• Advancements in Treatment: Improvements in medication formulation and the growing adoption of ACE inhibitors for chronic disorders are significant factors.
• Growing Demand for Affordable Drugs: The need for less expensive yet effective drugs, especially in emerging markets, is boosting demand for ramipril[2][3][5].

Regional Analysis

The ramipril market exhibits significant regional variation:

• North America: This region holds a prominent share due to the high prevalence of hypertension and heart-related diseases.
• Europe: Europe follows closely, driven by a well-established healthcare infrastructure and a large geriatric population.
• Asia Pacific: This region is expected to witness substantial growth due to advancements in healthcare and increasing awareness about cardiovascular health[2][5].

Competitive Landscape

The ramipril market is highly competitive, with key players including Pfizer Inc., AstraZeneca PLC, Novartis AG, Sanofi S.A., and Teva Pharmaceutical Industries Ltd. These companies focus on product development, strategic collaborations, and mergers to strengthen their market position[2].

Market Projections

Future Growth

The ramipril market is anticipated to expand significantly from 2021 to 2031, driven by several factors:

• Increasing Prevalence of Cardiovascular Diseases: The growing incidence of high blood pressure and heart-related conditions will continue to drive demand.
• Advancements in Treatment: Continued improvements in medication formulation and the use of ACE inhibitors for chronic illnesses will propel the market.
• Research and Development: Expanded R&D on ramipril and increasing financial contributions from governing bodies will create new opportunities[2][3][5].

Opportunities and Challenges

Opportunities

• Untapped Emerging Markets: Emerging economies with growing healthcare infrastructure offer significant market potential.
• Combination Therapy Approaches: Developing fixed-dose combination products with other antihypertensive drugs presents opportunities for market growth[2][5].

Challenges

• Alternative Treatment Options: The presence of alternative treatments and potential side effects associated with ramipril may pose challenges.
• Side Effects: Common side effects such as cough and potential interactions with other medications need to be managed effectively[2][4].

Key Takeaways

• Clinical Efficacy: Ramipril has been proven effective in reducing cardiovascular events in high-risk patients but showed no significant benefit in COVID-19 treatment.
• Market Growth: The global ramipril market is expected to grow significantly, driven by the increasing prevalence of cardiovascular diseases and advancements in treatment.
• Regional Variations: North America, Europe, and Asia Pacific are key regions, with Asia Pacific expected to see considerable growth.
• Competitive Landscape: The market is highly competitive, with major pharmaceutical companies focusing on product innovation and strategic collaborations.

FAQs

What is the primary use of ramipril?

Ramipril is primarily used to treat high blood pressure, heart failure, and to prevent cardiovascular events such as myocardial infarction and stroke.

What were the findings of the RAMIC trial?

The RAMIC trial found that de novo ramipril treatment did not significantly improve or worsen clinical outcomes for COVID-19 patients compared to placebo but appeared safe for non-critically ill patients.

What is the projected growth rate of the ramipril market?

The ramipril market is projected to grow at a CAGR of 3.6% from 2021 to 2029, reaching a value of USD 729.86 million by 2029.

Which regions are expected to drive the growth of the ramipril market?

North America, Europe, and Asia Pacific are expected to be the major drivers of the ramipril market growth, with Asia Pacific showing considerable potential due to advancements in healthcare.

What are the key drivers of the ramipril market?

The key drivers include the rising prevalence of cardiovascular diseases, advancements in treatment, and the growing demand for affordable and effective drugs.

Who are the major players in the ramipril market?

Major players include Pfizer Inc., AstraZeneca PLC, Novartis AG, Sanofi S.A., and Teva Pharmaceutical Industries Ltd.

Sources

1. RAMIC Trial: "Ramipril for the Treatment of COVID-19: RAMIC, a Randomized, Multicenter, Placebo-Controlled, Double-Blind, Allocation-Concealed Clinical Trial" - PubMed.
2. Ramipril Market Report: "Ramipril Market 2024-2032 | Size, Share, Growth" - MarkWide Research.
3. Global Ramipril Market: "Ramipril Market Size, Scope & Growth Opportunities By 2029" - Data Bridge Market Research.
4. HOPE Study: "The Heart Outcomes Prevention Evaluation Study - HOPE - Ramipril" - American College of Cardiology.
5. Ramipril Market Outlook: "Ramipril Market Market Outlook, Competitive Landscape and Forecasts to 2031" - BioSpace.