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Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects With Hypertension Requiring Antihypertensive Therapy
Phase 3 trial testing Over-encapsulated 10 mg amlodipine besylate tablet in Hypertension in 152 participants. Completed in 19 November 2015.
| Lead sponsor | Kitov Pharmaceuticals, Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 152 |
| Start date | 26 June 2014 |
| Primary completion | 19 November 2015 |
| Estimated completion | 19 November 2015 |
| Sites | 10 locations across United Kingdom |
Kitov Pharmaceuticals, Ltd. — full company profile →
Adults 40 to 75, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Amlodipine+Celecoxib | -10.6 | ± 9.2 |
| Amlodipine+Placebo | -8.83 | ± 8.13 |
| Placebo+Celecoxib | -0.5 | ± 8.8 |
| Placebo+Placebo | -2.11 | ± 8.2 |
Including any untoward medical occurrence in a participant administered study drug, which do not necessarily have a causal relationship with the study drug \[i.e., any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug\].
| Group | Value | 95% CI |
|---|---|---|
| Amlodipine+Celecoxib | 27 | |
| Amlodipine+Placebo | 28 | |
| Placebo+Celecoxib | 14 | |
| Placebo+Placebo | 10 |
| Group | Value | 95% CI |
|---|---|---|
| Amlodipine+Celecoxib | -10.3 | ± 8.9 |
| Amlodipine+Placebo | -8.02 | ± 7.6 |
| Placebo+Celecoxib | -0.5 | ± 7.8 |
| Placebo+Placebo | -1.19 | ± 5.87 |
| Group | Value | 95% CI |
|---|---|---|
| Amlodipine+Celecoxib | -10.5 | ± 10.6 |
| Amlodipine+Placebo | -6.35 | ± 11.35 |
| Placebo+Celecoxib | -1.7 | ± 12.3 |
| Placebo+Placebo | -1.42 | ± 9.15 |
| Group | Value | 95% CI |
|---|---|---|
| Amlodipine+Celecoxib | -7.1 | ± 5.6 |
| Amlodipine+Placebo | -4.8 | ± 4.83 |
| Placebo+Celecoxib | -0.5 | ± 4.6 |
| Placebo+Placebo | 0.22 | ± 4.28 |
| Group | Value | 95% CI |
|---|---|---|
| Amlodipine+Celecoxib | -7.5 | ± 6.4 |
| Amlodipine+Placebo | -5.53 | ± 5.06 |
| Placebo+Celecoxib | -1.5 | ± 5.6 |
| Placebo+Placebo | -0.32 | ± 5.39 |
| Group | Value | 95% CI |
|---|---|---|
| Amlodipine+Celecoxib | -7.0 | ± 8.6 |
| Amlodipine+Placebo | -3.23 | ± 7.79 |
| Placebo+Celecoxib | 0.3 | ± 7.1 |
| Placebo+Placebo | 0.01 | ± 6.23 |
| Group | Value | 95% CI |
|---|---|---|
| Amlodipine+Celecoxib | 15,800.83 | ± 4,161.929 |
| Amlodipine+Placebo | 23,453 | ± 5,746.337 |
| Group | Value | 95% CI |
|---|---|---|
| Amlodipine+Celecoxib | 139.708 | ± 86.504 |
| Placebo+Celecoxib | 138.667 | ± 118.811 |
| Group | Value | 95% CI |
|---|---|---|
| Amlodipine+Celecoxib | 9.634 | ± 0.268 |
| Amlodipine+Placebo | 10.025 | ± 0.310 |
| Group | Value | 95% CI |
|---|---|---|
| Amlodipine+Celecoxib | 4.785 | ± 0.564 |
| Placebo+Celecoxib | 4.636 | ± 0.781 |
| Group | Value | 95% CI |
|---|---|---|
| Amlodipine+Celecoxib | -10.6 | ± 9.2 |
| Amlodipine+Placebo | -8.83 | ± 8.13 |
| Placebo+Celecoxib | -0.5 | ± 8.8 |
| Placebo+Placebo | -2.11 | ± 8.2 |
Time frame: 1 month. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Amlodipine+Celecoxib | Amlodipine+Placebo | Placebo+Celecoxib | Placebo+Placebo |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Joint swelling | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Gout | Metabolism and nutrition disorders | — | — | — | — |
| Orthostatic hypotension | Vascular disorders | — | — | — | — |
Data from ClinicalTrials.gov NCT02172040 adverse events section.
The purpose of this study was to evaluate the effect of celecoxib on the efficacy and safety of amlodipine besylate in subjects with newly diagnosed hypertension requiring antihypertensive therapy. This study was conducted to support a future marketing application for KIT-302. Kitov Pharma Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug product (FCDP) consisting of the calcium channel blocker amlodipine besylate and the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, as a "convenience reformulation" FCDP to facilitate and improve patient compliance with the once a day (qd) administration of its individual components, amlodipine and celecoxib. The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a single immediate release tablet. However, for this study, two separate capsules were utilized: one containing a commercial celecoxib capsule (Celebrex®) or matched placebo capsule and one containing a commercial amlodipine besylate tablet (Norvasc®) or matched placebo tablet. The study hypothesis was that treatment with the amlodipine besylate containing capsule plus the celecoxib containing capsule would reduce blood pressure (BP) in subjects with hypertension with an efficacy that is not substantially inferior to the effect of amlodipine besylate alone (i.e., the amlodipine containing capsule plus the matched placebo for the celecoxib capsule). The United States (US) Food and Drug Administration (FDA) recently approved KIT-302, under the brand name Consensi® (amlodipine and celecoxib) tablets \[New Drug Application (NDA) 210045\] for the following indication: "patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions."
1 peer-reviewed publication reference this trial (live from Europe PMC):
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