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OE amlodipine · 1 trial · 1 indication
An ambulatory blood pressure monitor (ABPM) fitted to upper arm was used for continuous recording of blood pressure over three 25-hour periods: Days -1 to 0 (Baseline), Days 6 to 7, \& Days 13 to 14. The ABPM recorded blood pressure every 20 minutes between 09:00 and 21:59 and every 30 minutes between 22:00 and 08:59. SBPday was calculated by averaging all of the systolic blood pressure measurements between the protocol-defined first \& last study measurements of the period that fell between 9:00 and 21:00; measurements during the first hour (white-coat window) were not included. Change in SBPday was calculated by subtracting the Baseline value from the end of study value (Day 13 to Day 14 period). If the Day 13 to Day 14 value was not available, the Day 6 to Day 7 value was used \[last observation carried forward (LOCF) method\]. A negative value for change in SBPday indicates a decrease in systolic blood pressure and a positive value indicates an increase.
| Arm | Type | Description |
|---|---|---|
| Amlodipine+Celecoxib | EXPERIMENTAL | OE 10 mg amlodipine besylate tablet + OE 200 mg celecoxib capsule qd for 14 days |
| Amlodipine+Placebo | ACTIVE_COMPARATOR | OE 10 mg amlodipine besylate tablet + matched placebo for OE celecoxib capsule qd for 14 days |
| Placebo+Placebo | SHAM_COMPARATOR | Matched placebo for OE amlodipine besylate tablet + matched placebo for OE celecoxib capsule qd for 14 days |
| Name | Type | Description |
|---|---|---|
| OE 10 mg amlodipine besylate tablet | DRUG | - |
| OE 200 mg celecoxib capsule | DRUG | - |
| Matched placebo for OE amlodipine besylate tablet | DRUG | - |
| Matched placebo for OE celecoxib capsule | DRUG | - |
Inclusion Criteria: 1. Adult 40 to 75 years of age 2. Existing hypertension that is being treated using pharmacological therapy with a single agent that is not a calcium channel blocker 3. SBPday \> 135 and ≤ 169 mmHg and average daytime (9:00 to 21:00) ambulatory diastolic blood pressure (DBPday) ...
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OE amlodipine is an investigational small molecule developed by Purple Biotech Ltd. (ticker PPBT) for hypertension. It is also known as OE 10 mg amlodipine besylate tablet. The drug has completed a Phase 3 clinical trial in adults with existing hypertension requiring antihypertensive therapy.
OE amlodipine is being developed for the treatment of hypertension in adults. It is intended for patients with existing hypertension who require antihypertensive medication. The clinical program has focused on this cardiovascular indication, with a completed Phase 3 trial evaluating its use in that population.
OE amlodipine is developed by Purple Biotech Ltd., which trades under the ticker PPBT. The company is responsible for the clinical development of the OE 10 mg amlodipine besylate tablet formulation for hypertension.
OE amlodipine has completed a Phase 3 clinical trial. It is an investigational product and has not been approved by the FDA for any indication. The Phase 3 study has been completed, and no active trials are currently listed for this asset.
OE amlodipine has been studied in one completed Phase 3 trial, NCT02979197, titled Evaluation of Celecoxib Effects on Amlodipine in Subjects With Existing Hypertension Requiring Antihypertensives. The trial enrolled 105 participants in the United Kingdom, was randomized, double-blind, and active-controlled, and included adults aged 40 years and older.