Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Over-encapsulated amlodipine · 1 trial · 1 indication
Including any untoward medical occurrence in a participant administered study drug, which do not necessarily have a causal relationship with the study drug \[i.e., any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug\].
| Arm | Type | Description |
|---|---|---|
| Amlodipine+Celecoxib | EXPERIMENTAL | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks |
| Amlodipine+Placebo | ACTIVE_COMPARATOR | Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks |
| Placebo+Celecoxib | PLACEBO_COMPARATOR | Matched placebo capsule for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks |
| Placebo+Placebo | SHAM_COMPARATOR | Matched placebo capsule for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks |
| Name | Type | Description |
|---|---|---|
| Over-encapsulated 10 mg amlodipine besylate tablet | DRUG | Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks |
| Matched placebo capsule for over-encapsulated celecoxib capsule | DRUG | Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks |
| Over-encapsulated 200 mg celecoxib capsule | DRUG | Over-encapsulated 200 mg celecoxib capsule once a day for two weeks |
| Matched placebo capsule for over-encapsulated amlodipine besylate tablet | DRUG | Matched placebo capsule for over-encapsulated amlodipine besylate tablet once a day for two weeks |
Inclusion Criteria: 1. Adult 40 to 75 years of age 2. Newly diagnosed hypertension that requires chronic pharmacological therapy. Specifically, the subject must meet both of the following criteria: 1. Resting systolic BP ≥140 mmHg and ≤179 mmHg (where resting is defined as supine for at least 1...
Over-encapsulated amlodipine is used for the treatment of hypertension, a condition of persistently high blood pressure. It is being developed as a small molecule therapy for this cardiovascular indication. The drug is currently in Phase 3 clinical development, meaning it is still investigational and has not yet been approved for use.
Over-encapsulated amlodipine is being developed by Purple Biotech Ltd., a biopharmaceutical company. The company's stock is traded under the ticker symbol PPBT. Purple Biotech is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of hypertension.
Over-encapsulated amlodipine is in Phase 3 clinical development for hypertension. This is an investigational drug, meaning it has not yet received regulatory approval. The Phase 3 trial has been completed, and the results will help determine whether the drug can be submitted for approval.
Over-encapsulated amlodipine has one completed clinical trial, identified as NCT02172040. This Phase 3 study evaluated the effect of celecoxib on the efficacy and safety of amlodipine in subjects with hypertension requiring antihypertensive therapy. The trial enrolled 152 participants in the United Kingdom and was randomized, double-blind, and placebo-controlled.
Over-encapsulated amlodipine is a formulation of amlodipine, a well-known calcium channel blocker used to treat high blood pressure. The over-encapsulation refers to a specific method of drug delivery. In the clinical trial, the drug was studied in combination with celecoxib to assess potential interactions.