Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02979197 | Evaluation of Celecoxib Effects on Amlodipine in Subjects With Existing Hypertension Requiring Antihypertensives | PHASE3 | COMPLETED | 105 | — | — | Nov 3, 2016 | Jul 21, 2017 | Oct 21, 2019 | 9 | United Kingdom |
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) ...