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Placebo (for Pravastatin)
A placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect.
A placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect. Used for Control arm in pravastatin clinical trials (hyperlipidemia, cardiovascular disease prevention).
At a glance
| Generic name | Placebo (for Pravastatin) |
|---|---|
| Sponsor | Samsung Medical Center |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Placebo is an inert substance used as a control in clinical trials to establish baseline efficacy and safety of an active drug. Any observed effects are attributed to the placebo effect—psychological and physiological responses to the expectation of treatment rather than the substance itself. In this context, it serves as the comparator arm in pravastatin efficacy and safety studies.
Approved indications
- Control arm in pravastatin clinical trials (hyperlipidemia, cardiovascular disease prevention)
Common side effects
- Placebo effect (symptom improvement unrelated to active drug)
- Adverse events attributable to expectation or underlying disease progression
Key clinical trials
- Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial) (PHASE2)
- Statin Therapy in Patients With Early Stage ADPKD (PHASE4)
- Pravastatin for Prevention of Preeclampsia (PHASE1)
- An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (PHASE3)
- Effect of Statin Use on Aldosterone Secretion (PHASE1)
- Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL) (PHASE3)
- Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL (PHASE3)
- A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |