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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02172040 | Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects With Hypertension Requiring Antihypertensive Therapy | PHASE3 | COMPLETED | 152 | — | — | Jun 26, 2014 | Nov 19, 2015 | Oct 10, 2018 | 10 | United Kingdom |
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...