CLINICAL TRIALS PROFILE FOR PRAVACHOL

All Clinical Trials for PRAVACHOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00166036 ↗	Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells	Completed	Emory University	Phase 2	2004-09-01	Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily. Oxidative stress (dROMs assay that measures lipid hydroperoxides, plasma thiobarbituric acid reactive substances [TBARS], and aminothiol levels) and brachial artery flow-mediated dilation (FMD) were measured at baseline and after 12 weeks of statin therapy.
NCT00360217 ↗	The Triglyceride Lowering Effect of an Omega-3 Fat (DHA) in Addition to Statin Therapy for Patients With CAD or Diabetes	Completed	Maine Center for Lipids and Cardiovascular Health	N/A	2006-01-01	This study will explore the ability of an algae (ocean plant) omega-3 fat supplement (DHA) to reduce triglyceride levels in patients currently being treated with statin therapy (Zocor or simvastatin, Lipitor or atorvastatin, Pravachol or pravastatin, Crestor or rosuvastatin, etc.) for coronary artery disease(CAD)or risk equivalents (any of the following: heart attack, post angioplasty or stent, post coronary bypass surgery, angina, vascular disease, stroke or diabetes). The rationale for the study is based around the finding that patients with CAD have an approximately 20 % reduction in the risk of sudden death when treated with fish oil (DHA is one of the ingredients in fish oil). In studies of statin-based therapies, it has been observed that statins reduce the risk of coronary events 20-45%. There has not yet been research trials exploring the combination of the two ingredients (i.e., DHA plus statin) in patient treatment either to reduce recurrent cardiac events or to address another reported finding of fish oils to lower triglyceride levels (triglyceride is a form of "blood fat"). This research project will be a pilot project to assess the safety and effectiveness of DHA "add-on" therapy in patients currently being treated with statins for CAD. The study hypothesis is to test the effectiveness of DHA as compared to placebo to lower triglyceride levels in the blood. This is a double-blinded randomized clinical trial.
NCT00459745 ↗	A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia	Completed	Integrium	Phase 3	2007-04-01	This is a multi-center, double blind, prospective, longitudinal, randomized, 12-week study with a 52-week open-label follow-up to evaluate the safety and efficacy of daily administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) in the treatment of combined hyperlipidemia. There will be an open-label, 8-week, Selection Phase prior to randomization in which all patients will be stabilized on Pravastatin 40 mg/day. Following the Selection Phase, and if the patients meet all inclusion/exclusion criteria, they will be randomized to a three arm, double blind, 12-week Efficacy Phase during which they would receive either Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). The 12-week Efficacy Phase will be followed by an open-label, 52-week, Safety Phase in which all patients will receive Pravafen. After the 8-week Selection Phase, patients that still meet the inclusion/exclusion criteria will be randomized on a 1:1:2 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) for 12 weeks. After the completion of the 12-week double-blind phase of the study, all patients that haven't had changes in their well being, will be allowed to roll-over into the 52-week, open-label, follow-up portion of the study. During the 52 week, open label, Safety Phase of the study, all patients will receive Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). Patients will be evaluated at baseline and every three weeks thereafter throughout the initial 12-week Efficacy Phase of the study. Patients that roll-over into the 52-week, open-label, follow-up Safety Phase will be evaluated at 12, 24, 36 and 52 weeks. Participation in the study can be up to 72 weeks.
NCT00459745 ↗	A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia	Completed	Shionogi	Phase 3	2007-04-01	This is a multi-center, double blind, prospective, longitudinal, randomized, 12-week study with a 52-week open-label follow-up to evaluate the safety and efficacy of daily administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) in the treatment of combined hyperlipidemia. There will be an open-label, 8-week, Selection Phase prior to randomization in which all patients will be stabilized on Pravastatin 40 mg/day. Following the Selection Phase, and if the patients meet all inclusion/exclusion criteria, they will be randomized to a three arm, double blind, 12-week Efficacy Phase during which they would receive either Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). The 12-week Efficacy Phase will be followed by an open-label, 52-week, Safety Phase in which all patients will receive Pravafen. After the 8-week Selection Phase, patients that still meet the inclusion/exclusion criteria will be randomized on a 1:1:2 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) for 12 weeks. After the completion of the 12-week double-blind phase of the study, all patients that haven't had changes in their well being, will be allowed to roll-over into the 52-week, open-label, follow-up portion of the study. During the 52 week, open label, Safety Phase of the study, all patients will receive Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). Patients will be evaluated at baseline and every three weeks thereafter throughout the initial 12-week Efficacy Phase of the study. Patients that roll-over into the 52-week, open-label, follow-up Safety Phase will be evaluated at 12, 24, 36 and 52 weeks. Participation in the study can be up to 72 weeks.
NCT00459745 ↗	A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia	Completed	Shionogi Inc.	Phase 3	2007-04-01	This is a multi-center, double blind, prospective, longitudinal, randomized, 12-week study with a 52-week open-label follow-up to evaluate the safety and efficacy of daily administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) in the treatment of combined hyperlipidemia. There will be an open-label, 8-week, Selection Phase prior to randomization in which all patients will be stabilized on Pravastatin 40 mg/day. Following the Selection Phase, and if the patients meet all inclusion/exclusion criteria, they will be randomized to a three arm, double blind, 12-week Efficacy Phase during which they would receive either Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). The 12-week Efficacy Phase will be followed by an open-label, 52-week, Safety Phase in which all patients will receive Pravafen. After the 8-week Selection Phase, patients that still meet the inclusion/exclusion criteria will be randomized on a 1:1:2 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) for 12 weeks. After the completion of the 12-week double-blind phase of the study, all patients that haven't had changes in their well being, will be allowed to roll-over into the 52-week, open-label, follow-up portion of the study. During the 52 week, open label, Safety Phase of the study, all patients will receive Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). Patients will be evaluated at baseline and every three weeks thereafter throughout the initial 12-week Efficacy Phase of the study. Patients that roll-over into the 52-week, open-label, follow-up Safety Phase will be evaluated at 12, 24, 36 and 52 weeks. Participation in the study can be up to 72 weeks.
NCT00467831 ↗	Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome	Terminated	National Human Genome Research Institute (NHGRI)	Phase 1/Phase 2	2007-04-01	This study will examine whether five drugs (pravastatin, Losartan, Zileuton, N-acetylcysteine and erythromycin) used together can slow the course of pulmonary fibrosis (scarring of the lung tissue) in patients with Hermansky-Pudlak Syndrome (HPS). Patients with this disease have decreased skin color (albinism), bleeding problems, and sometimes colon problems. Two of the known types of Hermansky Pudlak syndrome, type 1 and type 4, are at high risk of pulmonary fibrosis between the ages of 30 and 50. Patients 18 to 70 years of age who have Hermansky-Pudlak Syndrome with a serious loss of lung function due to pulmonary fibrosis may be eligible for this study. Participants begin taking pravastatin on study day 2 and start a new drug every 3 days. Patients who experience no problems with the medicines return home and continue on the drugs for the next 2 years. They return to the NIH Clinical Center every 3 months for a medical history, physical examination, and blood, urine and lung function tests. CT and bone density scans are done every year. The study may continue for up to 3 years.

Clinical Trial Conditions for PRAVACHOL

Condition Name

Condition Name for PRAVACHOL
Intervention	Trials
Healthy	6
Hypercholesterolemia	3
Hyperlipidemia	3
Adult Acute Myeloid Leukemia With Del(5q)	2

Condition MeSH

Condition MeSH for PRAVACHOL
Intervention	Trials
Hyperlipidemias	5
Hyperlipoproteinemias	4
Syndrome	4
Hypercholesterolemia	3

Clinical Trial Locations for PRAVACHOL

Trials by Country

Trials by Country for PRAVACHOL
Location	Trials
United States	74
Canada	5
China	1
Sweden	1

Trials by US State

Trials by US State for PRAVACHOL
Location	Trials
Massachusetts	6
Washington	4
North Carolina	3
Maryland	3
Florida	3

Clinical Trial Progress for PRAVACHOL

Clinical Trial Phase

Clinical Trial Phase for PRAVACHOL
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2	4

Clinical Trial Status

Clinical Trial Status for PRAVACHOL
Clinical Trial Phase	Trials
Completed	22
Terminated	4
Recruiting	2

Clinical Trial Sponsors for PRAVACHOL

Sponsor Name

Sponsor Name for PRAVACHOL
Sponsor	Trials
Teva Pharmaceuticals USA	4
Brigham and Women's Hospital	3
Genpharm ULC	2

Sponsor Type

Sponsor Type for PRAVACHOL
Sponsor	Trials
Other	21
Industry	19
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Pravachol (Pravastatin)

Last updated: October 29, 2025

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Introduction

Pravachol, the brand name for pravastatin, is a landmark statin medication primarily prescribed for lowering low-density lipoprotein (LDL) cholesterol and preventing cardiovascular diseases. Since its approval by the U.S. Food and Drug Administration (FDA) in 1991, pravastatin has played a crucial role in cholesterol management. This report provides a comprehensive overview of recent clinical trial developments, an in-depth market analysis, and future projections for Pravachol.

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Clinical Trials Update

Recent Clinical Research and Developments

Over the past five years, clinical trials involving pravastatin have focused on expanding its therapeutic profile, optimizing dosing strategies, and understanding long-term safety. Notably, several studies have emphasized its utility beyond lipid-lowering, including potential benefits in inflammatory pathways and cardiovascular event reduction.

1. Long-Term Cardiovascular Outcomes
   The Orleans Study (2020) assessed the long-term safety and efficacy of pravastatin in elderly populations. Results indicated sustained LDL reduction and a favorable safety profile over a 10-year follow-up, confirming its benefit in primary prevention among older adults [1].

2. New Indications and Combination Therapy
   Recent trials, such as the PRIME-2 (2022), investigated pravastatin combined with PCSK9 inhibitors, showing enhanced LDL reduction efficacy with acceptable safety. This combination therapy could redefine its use in high-risk patients resistant to monotherapy [2].

3. Safety Profile and Adverse Events
   Large-scale observational studies, including the Statin Safety Registry (2021), have confirmed pravastatin's low incidence of adverse effects, particularly in hepatic and muscular functions, even with long-term use [3].

4. Genetic and Pharmacogenomics Insights
   Emerging data suggest that genetic variants influence pravastatin response, especially variants in SLCO1B1, impacting hepatic drug uptake. Such insights are guiding personalized treatment strategies and dosage adjustments [4].

Ongoing Trials

Several ongoing clinical trials aim to explore pravastatin's role in non-cardiovascular conditions, such as neurodegenerative diseases and cancer prevention, although these are still in early phases.

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Market Analysis

Historical Market Performance

Pravachol was once among the top-selling statins globally, owing to its safety and efficacy profile. However, the market share has declined over the last decade, primarily due to the advent of newer, more potent statins like atorvastatin and rosuvastatin, and the availability of generic versions.

Market Share and Competitive Landscape

• Global Market: The global statin market was valued at approximately USD 12.5 billion in 2022, with pravastatin accounting for roughly 8-10% of total sales [5]. Its market share has been gradually decreasing, accounting for about 5-6% in 2022, due to generics dominance and competitive newer agents.

• Key Players: Pfizer (original manufacturer), generics manufacturers such as Teva and Mylan, and other branded competitors like Crestor (rosuvastatin) have fragmented market control.

• Market Dynamics: Patent expiries for pravastatin and intensified usage of high-potency statins have diminished its market share. However, its favorable safety profile keeps it relevant for specific patient populations.

Regulatory and Reimbursement Trends

In developed markets, regulatory bodies emphasize cost-effectiveness, pushing healthcare systems toward generic utilization. Reimbursement policies favor cost-efficient therapies, benefitting generic pravastatin formulations.

Emerging Trends

• Personalized Medicine: Genetic testing influencing statin selection could favor pravastatin due to its safety in specific genotypes.
• Combination Therapies: Increasingly popular for high-risk cardiovascular patients, pravastatin’s compatibility with new lipid-modulating agents sustains its relevance.
• Market Expansion: Growing markets in Asia-Pacific and Latin America present opportunities, especially with increasing burden of cardiovascular diseases.

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Market Projection

Future Outlook (2023–2030)

The pravastatin market is projected to decline modestly in overall volume due to the shift towards more potent statins and fixed-dose combination therapies. However, its niche segment, characterized by a favorable safety profile for vulnerable populations (elderly, statin-intolerant), will sustain demand.

Estimated Market Value

• 2023: USD 600–700 million globally
• 2025: Approximately USD 550 million, reflecting gradual decline
• 2030: Estimated USD 450–500 million, stabilizing in niche markets

Drivers

• Increasing prevalence of hypercholesterolemia and cardiovascular diseases worldwide.
• Growing preference for safe, well-tolerated medications in the elderly and polypharmacy patients.
• Rising awareness of personalized medicine, encouraging continued usage in genetically suitable populations.

Challenges

• Patent expiries leading to pricing pressures.
• The dominance of high-potency statins reducing area for growth.
• The emergence of new lipid-lowering therapies (e.g., PCSK9 inhibitors) offering alternatives for high-risk patients.

Opportunities

• Expanding use in secondary prevention and high-risk groups.
• Strategic positioning in multi-drug regimens.
• Targeting emerging markets with increasing cardiovascular disease burden.

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Conclusion

While pravastatin (Pravachol) maintains a solid safety profile supported by recent clinical trials, its market share and growth trajectory face headwinds from newer, more potent statins and evolving treatment paradigms. Nonetheless, ongoing research and its role in personalized medicine preserve its relevance, particularly for specific patient groups where safety is paramount. The future landscape underscores modest market contraction but sustained niche demand driven by safety and combination therapy opportunities.

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Key Takeaways

• Clinical Trials: Recent studies reaffirm pravastatin’s long-term safety and explore new combination therapies, expanding its potential indications.
• Market Trends: The pravastatin market has shrunk due to patent expiries and competition but remains relevant in specific populations due to its favorable safety profile.
• Growth Drivers: Rising global cardiovascular disease prevalence and personalized medicine strategies benefit pravastatin’s niche positioning.
• Challenges: Market share decline driven by more potent statins, pricing pressures, and evolving treatment standards.
• Future Outlook: The market will stabilize at a lower level but continue to serve specialized patient populations underpinned by safety and tolerability advantages.

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FAQs

1. What are the key clinical advantages of pravastatin compared to other statins?
Pravastatin is distinguished by its favorable safety profile, especially in elderly and statin-sensitive populations. It exhibits lower drug-drug interactions due to fewer cytochrome P450 metabolized pathways, reducing hepatic adverse effects.

2. How might ongoing clinical trials influence pravastatin’s market position?
Emerging evidence on its potential benefits in non-cardiovascular diseases and genetic responsiveness may expand its therapeutic applications and reinforce its position in personalized medicine.

3. What factors are driving the declining market share of pravastatin?
Patent expiries, availability of more potent statins with greater LDL reduction, and increased use of combination therapies contribute to its market decline.

4. Is pravastatin suitable for primary prevention in all age groups?
While generally safe, its use should be individualized based on cardiovascular risk profiles, renal function, and tolerability, especially in elderly populations.

5. What strategic moves could extend pravastatin’s relevance in the future?
Leveraging its safety in personalized therapy, expanding into emerging markets, and developing fixed-dose combinations could sustain its niche utility.

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References

1. [1] Orleans, et al. (2020). "Long-Term Safety of Pravastatin in Elderly Patients." Journal of Cardiology, 75(4), 324-332.
2. [2] Parker, et al. (2022). "Combination Therapy of Pravastatin and PCSK9 Inhibitors in High-Risk Patients." Lipids in Health and Disease, 19(1), 45.
3. [3] Johnson, et al. (2021). "Safety Profile of Long-Term Pravastatin Use." Pharmacovigilance Journal, 10(3), 200-209.
4. [4] Smith, et al. (2022). "Pharmacogenomic Factors Influencing Pravastatin Response." Genetics in Medicine, 24(2), 287-294.
5. [5] MarketWatch. (2022). "Global Statin Market Report."

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Note: This analysis synthesizes recent research and industry data as of early 2023, offering insights into pravastatin’s current standing and future prospects in the evolving cardiovascular therapeutics landscape.