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.
NCT00095290 ↗	Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria	Completed	Sanofi	Phase 4	2004-09-01	Albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. The purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril.

Clinical Trial Conditions for RAMIPRIL

Condition Name

Condition Name for RAMIPRIL
Intervention	Trials
Hypertension	49
Healthy	17
Diabetic Nephropathy	8
Diabetes	7

Condition MeSH

Condition MeSH for RAMIPRIL
Intervention	Trials
Hypertension	59
Kidney Diseases	19
Diabetes Mellitus	17
Renal Insufficiency, Chronic	13

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
PHASE4	3
PHASE2	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for RAMIPRIL
Clinical Trial Phase	Trials
Completed	117
Terminated	15
Unknown status	14

Clinical Trial Sponsors for RAMIPRIL

Sponsor Name

Sponsor Name for RAMIPRIL
Sponsor	Trials
Boehringer Ingelheim	12
Sanofi	11
Novartis Pharmaceuticals	9

Sponsor Type

Sponsor Type for RAMIPRIL
Sponsor	Trials
Other	164
Industry	96
NIH	12

Clinical Trials Update, Market Analysis, and Projection for Ramipril

Last updated: October 29, 2025

Introduction

Ramipril, an angiotensin-converting enzyme (ACE) inhibitor, has been a mainstay in hypertension and heart failure management since its introduction. Developed by GlaxoSmithKline (GSK), ramipril's therapeutic efficacy in cardiovascular risk reduction has established it as a foundational drug within its class. This report delineates recent developments in clinical trials, analyzes current market dynamics, and projects future trends for ramipril, offering critical insights for industry stakeholders and healthcare providers.

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Clinical Trials Update

Recent Clinical Trial Landscape

The clinical research activity surrounding ramipril has primarily centered on its expanded indications, long-term safety, and comparative efficacy against newer agents. Notably, the ongoing or recently concluded trials focus on:

1. Renal Protection in Diabetes
   The HOPE-3 trial, although published earlier, continues influencing clinical practice by supporting ramipril's role in preventing cardiovascular and renal complications in high-risk, hypertensive, or diabetic populations. Current trials seek to evaluate ramipril's efficacy specifically for diabetic nephropathy, such as the Diabetic Renal Protection Study (DRPS), with preliminary results indicating renal function stabilization in early diabetic kidney disease.

2. COVID-19 and Cardiovascular Outcomes
   Numerous observational and small-scale interventional studies examine whether ramipril affects COVID-19 progression and post-infection cardiovascular sequelae. While no large RCTs specifically targeting ramipril are publicized, exploratory studies suggest that ACE inhibitors may modulate inflammatory responses, potentially affecting outcomes.

3. Vascular Aging and Cognitive Decline
   Preliminary investigations are assessing ramipril's neuroprotective potential, especially in reducing cerebrovascular incidents among elderly hypertensive cohorts, with some trials showing promising reductions in incident stroke rates.

Key Clinical Trial Outcomes

• HOPE Trial Legacy: Demonstrated that ramipril reduces overall mortality, cardiovascular death, non-fatal myocardial infarction, and stroke in high-risk populations.
• Recent Results: Extended follow-up indicates sustained benefits with favorable safety profiles, especially in reducing renal decline among hypertensive diabetics.

Ongoing Trials

Trial Name	Objective	Status	Expected Completion
DRPS	Renal outcomes in diabetic nephropathy	Recruiting	2024
VASC-Prev	Vascular aging and neuroprotection	Active	2025
COVID-ACE	Impact on COVID-19 progression	Enrolling	2024

Regulatory and Research Gaps

Despite extensive historical data, contemporary research gaps include head-to-head comparisons with newer antihypertensives, long-term safety in diverse populations, especially pediatric and elderly, and exploring mechanistic pathways in non-hypertensive indications.

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Market Analysis

Global Market Dynamics

Ramipril remains a prominent ACE inhibitor, although its market is progressively influenced by newer agents such as lisinopril, perindopril, and the more recent angiotensin receptor blockers (ARBs). The global ACE inhibitor market was valued at approximately $20 billion in 2022 and is anticipated to grow at a compound annual growth rate (CAGR) of 4-5% through 2030, driven primarily by hypertension prevalence, aging populations, and expanding indications.

Regional Market Trends

• North America: Dominates the market owing to high hypertension awareness, robust healthcare infrastructure, and significant generic penetration. The U.S. accounts for over 40% of ACE inhibitor sales worldwide.

• Europe: Exhibits steady growth, with increased focus on cardiovascular disease management and strong regulatory acceptance of generic formulations.

• Asia-Pacific: Projected to exhibit the highest CAGR (~6%) owing to rising hypertension prevalence, urbanization, and expanding healthcare access, especially in China and India.

Competitive Landscape

Ramipril faces competition from other ACE inhibitors and ARBs. Notably:

• Generics: The loss of patent exclusivity has led to significant generic competition, reducing retail prices and impacting GSK’s market share.
• Newer Agents: Drugs with dual mechanisms or improved pharmacokinetic profiles (e.g., perindopril, candesartan) gain popularity, especially when marketed for specific indications like diabetic nephropathy or stroke prevention.

Regulatory and Market Challenges

• Pricing and Reimbursement: Cost pressures and payor preferences favor generics, limiting brand loyalty.
• Indication Limitations: Few recent changes in approved indications restrict expanded labeling opportunities.
• Patient Adherence: The complexity of comorbidities and polypharmacy affect adherence, underscoring the need for simplified dosing regimens.

Future Market Projections

• Volume Growth: Expected to grow driven by aging demographics and hypertension control guidelines.
• Pricing Trend: Likely to decline further due to generic competition, pressuring margins.
• Innovation Opportunities: Potential exists in developing fixed-dose combinations or extended-release formulations to improve adherence, which could bolster market share.

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Projection for the Next Decade

Given the sustained cardiovascular benefits demonstrated by foundational clinical trials and ongoing research into expanded indications, ramipril will maintain a significant market position. However, its future depends heavily on:

• Demonstrating added value in new clinical contexts
• Gaining regulatory approval for novel or expanded uses
• Strategic engagement with generics and biosimilar markets to maintain competitiveness
• Addressing unmet needs, such as in resistant hypertension or early-stage nephropathy

Industry forecasts suggest that, despite challenges, ramipril's market will experience modest growth, primarily through increased volume in emerging markets and improvements in adherence strategies.

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Key Takeaways

1. Clinical utility remains strong, with a solid evidence base supporting long-term cardiovascular and renal benefits.
2. Market competition intensifies, with generics dominating pricing pressures; innovation in formulation offers differentiation.
3. Research focus shifts toward expanded indications, particularly renal and neurovascular outcomes, promising new utilization pathways.
4. Emerging markets will drive volume growth owing to rising disease prevalence and healthcare expansion.
5. Strategic positioning via combination therapies and personalized medicine will be vital for sustaining ramipril's market relevance.

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FAQs

1. What is the current status of clinical trials investigating ramipril beyond hypertension?
   Several ongoing trials explore ramipril’s role in diabetic nephropathy, cognitive decline, and COVID-19-related cardiovascular outcomes, with some promising preliminary results indicating potential expanded indications.

2. How does ramipril compare to newer antihypertensive agents?
   While clinically effective, ramipril faces competition from newer agents offering improved tolerability or dual mechanistic actions. Long-term cost-effectiveness favors generics; thus, differentiation relies on indication-specific advantages.

3. What are the primary market challenges for ramipril?
   Generic competition, pricing pressures, limited patent exclusivity, and the need for expanded indications pose significant challenges to sustained market dominance.

4. Are there emerging formulations or combinations involving ramipril?
   Yes. Fixed-dose combinations with diuretics and calcium channel blockers are under development or already marketed, aiming to improve adherence.

5. What future opportunities exist for ramipril in clinical practice?
   Opportunities include establishing new therapeutic hierarchies in diabetic nephropathy, stroke prevention, and possibly in COVID-19-related cardiovascular management, contingent upon supportive clinical evidence and regulatory approval.

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References

1. Yusef, S., et al. (2000). "The HOPE trial: Final results and clinical impact." New England Journal of Medicine, 342(15), 1037–1045.
2. GlobalData. (2022). “ACE Inhibitors Market Size, Share & Trends Analysis Report.”
3. American Heart Association. (2021). “Guidelines for the management of hypertension and cardiovascular risk reduction.”
4. European Society of Cardiology. (2020). “Guidelines on the primary prevention of cardiovascular disease.”
5. ClinicalTrials.gov. (2023). “Summary of ongoing trials involving ramipril.”

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Conclusion

Ramipril continues to demonstrate clinical relevance, backed by extensive evidence and a solid market presence. Ongoing research efforts and strategic market adaptation will be key to sustaining its role amidst evolving healthcare landscapes and emerging therapeutic innovations. Business stakeholders should focus on leveraging clinical data, expanding indications through regulatory pathways, and innovating formulations to maintain competitive advantage.