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.

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	14

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	4
PHASE2	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for ramipril
Clinical Trial Phase	Trials
Completed	117
Recruiting	15
Terminated	15

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	165
Industry	96
NIH	12

Ramipril: Clinical Trials Update and Market Outlook

Last updated: April 29, 2026

What is ramipril and where does it sit in the portfolio of cardiovascular therapy?

Ramipril is an ACE inhibitor used to treat hypertension, heart failure, and reduce cardiovascular events in high-risk patients. As an established, off-patent generic medicine in most jurisdictions, its commercial outlook is driven by utilization, pricing dynamics, guideline adherence, and regional competitive intensity rather than pipeline replacement.

What does the clinical trials landscape look like right now?

Ramipril’s ongoing clinical activity largely reflects studies that expand within-label evidence (different populations, dosing strategies, adherence models), life-cycle work (formulation/PK), and comparative effectiveness. The most visible trial activity is usually driven by:

• Generic sponsor life-cycle programs (bioequivalence, formulation, and switching studies)
• Registry and pragmatic trials tied to guideline implementation
• Sub-studies focused on renal outcomes, cardiovascular risk markers, and co-morbidity strata

Clinical trials update (current snapshot) A complete real-time update requires live database pulls. This answer cannot produce a complete and accurate “current” clinical trials inventory without that live data.

What is the market structure and how is ramipril priced?

Ramipril market economics are shaped by:

• Generic dominance: In most markets, ramipril is supplied by multiple generic manufacturers, which compresses gross pricing.
• Reimbursement and tendering: Pricing is frequently set through tender systems, payer formularies, and negotiated discounts.
• Switching and persistence: Generic substitution and persistence on therapy influence unit volumes more than clinical differentiation.
• Dose range breadth: Multiple strengths (commonly 1.25 mg, 2.5 mg, 5 mg, 10 mg) increase prescribing flexibility across patient profiles.

Implication for forecasting: revenue tends to track patient prevalence and treatment rates, not drug innovation. Price erosion is the primary risk; utilization and guideline adherence are the primary upside lever.

How should ramipril demand be projected?

A projection for ramipril should be built from three drivers:

1. Incidence and prevalence: burden of hypertension, heart failure, and high cardiovascular risk
2. Treatment penetration: proportion of eligible patients started on ACE inhibition
3. Adherence and persistence: discontinuation rates and medication switching

For ramipril specifically, demand is also influenced by:

• Safety and tolerability patterns (ACE inhibitor cough, hyperkalemia, renal function monitoring)
• Competing standard-of-care (ACE inhibitors versus ARBs, and in some sub-populations versus alternative drug classes)
• Local generic supply and contracting volatility

Market projection logic (directional)

• Volume: stable-to-growing in regions with rising cardiovascular disease prevalence and expanding access
• Revenue: flat-to-declining under continued generic price erosion
• Mix: potential mild shift toward higher-dose strengths and combination products where payers favor cost-effective dosing regimens

Where does competition come from and what threatens ramipril share?

Key competitive pressure typically comes from:

• Other ACE inhibitors (e.g., lisinopril, enalapril, perindopril) with strong local prescriber adoption
• ARBs (e.g., losartan, valsartan, telmisartan) where ACE intolerance prompts switching
• Combination strategies (ACE inhibitor plus diuretic or CCB) that can reduce monotherapy share

Share risk: ramipril’s risk is less “clinical displacement” and more “formularies and prescribing habits” within generic classes.

What are the main geographic and payer factors that can swing forecasts?

Ramipril outcomes vary by:

• Formulary status (preferred ACE inhibitor position)
• Tender outcomes (who wins volume)
• Indexing to originator vs generic baselines after major competitive entry waves
• National prescribing targets and guideline adoption speed

What investment and R&D signals matter for ramipril right now?

Ramipril is a “commercial manufacturing and formulation” story rather than a discovery pipeline story. R&D is typically directed toward:

• High-quality generics and line extensions (strengths, fixed-dose combinations where applicable)
• Extended-release or improved PK formulations (where local standards and payer incentives support it)
• Real-world evidence programs that strengthen payer confidence in switching and adherence

From a business perspective, the actionable signals are:

• Tender calendar and loss/win patterns at major buyers
• Margin compression trends in key regions
• Formulary preference shifts among ACE inhibitors and ARBs
• Contract manufacturing capacity and regulatory compliance

What would a robust market model look like for ramipril (framework for projection)?

A defensible model can be structured as follows:

Demand module

• Eligible population = estimated prevalence of hypertension + subset with heart failure or high cardiovascular risk
• Treated share = proportion on ACE inhibitors
• Patient-years on ramipril = treated share times persistence assumptions

Price module

• Net price = weighted tender/gross-to-net discounts
• Annual price erosion = region-specific generic compression factor
• Mix effect = distribution across strengths and combination vs monotherapy

Revenue module

• Revenue = patient-years on ramipril × net price

This framework consistently shows:

• Volume stability across macro cycles in most markets
• Revenue sensitivity to discounting and tender outcomes

Key regulatory and labeling considerations affecting utilization

ACE inhibitors as a class carry:

• Renal function monitoring expectations
• Potassium monitoring due to hyperkalemia risk
• Contraindications and precautions that affect initiation rates in frail populations

Ramipril utilization is also influenced by dosing titration practices and clinician adherence to monitoring schedules.

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Key Takeaways

• Ramipril is an off-patent ACE inhibitor; commercial performance is driven by utilization and net price dynamics, not clinical innovation.
• Current “clinical trials update” requires live trial database retrieval to be complete; without it, only directional characterization is possible here.
• Market projection should be modeled from patient-years on therapy (prevalence × penetration × persistence) and net price (tender and reimbursement dynamics).
• Main risks to revenue are continued generic price compression and formulary preference shifts within the ACE inhibitor and ARB classes.
• Actionable monitoring signals are tender outcomes, net price erosion rate, and prescribing share movement among ACE inhibitors and ARBs.

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FAQs

1) Is ramipril still under patent protection in major markets?
Ramipril is broadly generic in most jurisdictions, and commercial focus has shifted to generic manufacturing and formulary positioning rather than patent-based exclusivity.

2) What patient groups drive ramipril demand most?
Hypertension patients plus a substantial subset with heart failure and high cardiovascular risk.

3) What is the biggest threat to ramipril revenue?
Net price compression from generic competition and tender-driven discounting.

4) What is the biggest upside lever for ramipril volume?
Higher treatment penetration and persistence among eligible cardiovascular patients.

5) Do competitors typically displace ramipril clinically?
Competition often happens through formulary preference, switching patterns for ACE intolerance, and combination prescribing rather than major clinical discontinuities.

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References

[1] European Medicines Agency (EMA). Ramipril: EPAR (product information and safety/efficacy details by indications). EMA website.
[2] U.S. Food and Drug Administration (FDA). Labeling for ramipril products (ACE inhibitor class labeling and safety information). FDA website.
[3] World Health Organization (WHO). Cardiovascular disease burden and risk factor guidance relevant to antihypertensive utilization trends. WHO publications.
[4] NICE. Hypertension and cardiovascular risk management guidance (ACE inhibitor usage and monitoring principles). National Institute for Health and Care Excellence.