| Primary | Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Primary Endpoint | | Intent-to-treat (ITT): All randomized participants who received at least 1 dose of study drug and had at least a valid baseline ambulatory blood pressure monitor measurement (ABPM) and either: a) a valid Day 13-14 ABPM, where participant completed treatment or b) a valid Day 6-7 or Day 0-1 ABPM, where participant was withdrawn early. | Posted | | Mean | Standard Deviation | mmHg | | Baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine+Celecoxib | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks | | OG001 | Amlodipine+Placebo | Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks | | OG002 | Placebo+Celecoxib | Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks | | OG003 | Placebo+Placebo | Matched placebo tablet for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks |
| | Units | Counts |
|---|
| Participants | - OG00049
- OG00145
- OG00230
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-10.6± 9.2
- OG001-8.83± 8.13
- OG002-0.5± 8.8
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| A serial gatekeeping strategy was used for the primary efficacy endpoint analysis. The primary comparison was a two-sample t-test to test the one-sided hypothesis that treatment with amlodipine + celecoxib was non-inferior to half of the effect achieved with amlodipine. | t-test, 1 sided | | = 0.001 | | | | | | | | | | | | | | Non-Inferiority | Non-inferiority margin definition: lower limit of the 95% confidence interval (CI) for amlodipine + celecoxib arm did not cross the 50% value for the amlodipine arm. | |
|
| Primary | Frequency of Adverse Events (Number of Participants Affected/Number of Participants at Risk) | 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]. | Safety population: all randomized participants who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | 1 month | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine+Celecoxib | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks | | OG001 | Amlodipine+Placebo | Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks |
|
| Secondary | Mean Change in Average 24-hour Ambulatory Systolic Blood Pressure (SBP24h) | | ITT population as described for primary outcome | Posted | | Mean | Standard Deviation | mmHg | | Baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine+Celecoxib | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks | | OG001 | Amlodipine+Placebo | Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks | | OG002 | Placebo+Celecoxib | Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks |
|
| Secondary | Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Systolic Blood Pressure (SBPnight) | | ITT Population as described for primary outcome | Posted | | Mean | Standard Deviation | mmHg | | Baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine+Celecoxib | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks | | OG001 | Amlodipine+Placebo | Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks | | OG002 | Placebo+Celecoxib | Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks |
|
| Secondary | Mean Change in Average 24-hour Ambulatory Diastolic Blood Pressure (DBP24h) | | ITT Population as described for primary outcome | Posted | | Mean | Standard Deviation | mmHg | | Baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine+Celecoxib | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks | | OG001 | Amlodipine+Placebo | Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks | | OG002 | Placebo+Celecoxib | Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks |
|
| Secondary | Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Diastolic Blood Pressure (DBPday) | | ITT Population as described for primary outcome | Posted | | Mean | Standard Deviation | mmHg | | Baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine+Celecoxib | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks | | OG001 | Amlodipine+Placebo | Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks | | OG002 | Placebo+Celecoxib | Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks |
|
| Secondary | Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Diastolic Blood Pressure (DBPnight) | | ITT Population as defined for primary outcome | Posted | | Mean | Standard Deviation | mmHg | | Baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine+Celecoxib | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks | | OG001 | Amlodipine+Placebo | Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks | | OG002 | Placebo+Celecoxib | Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks |
|
| Secondary | Mean Non-transformed Amlodipine Plasma Concentration | | Pharmacokinetic (PK) population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No amlodipine PK statistical analyses were performed for the PK participants in the placebo+celecoxib and placebo+placebo arms. | Posted | | Mean | Standard Deviation | pg/mL | | 24 hours post-dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine+Celecoxib | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks | | OG001 | Amlodipine+Placebo | Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks |
| |
| Secondary | Mean Non-transformed Celecoxib Plasma Concentration | | PK population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No celecoxib PK statistical analyses were performed for the PK participants in the amlodipine+placebo and placebo+placebo arms. | Posted | | Mean | Standard Deviation | ng/mL | | 24 hours post-dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine+Celecoxib | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks | | OG001 | Placebo+Celecoxib | Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks |
| |
| Secondary | Mean Log-transformed Amlodipine Plasma Concentration | | PK population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No amlodipine PK statistical analyses were performed for the PK participants in the placebo+celecoxib and placebo+placebo arms. | Posted | | Mean | Standard Deviation | log(pg/mL) | | 24 hours post-dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine+Celecoxib | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks | | OG001 | Amlodipine+Placebo | Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks |
| |
| Secondary | Mean Log-transformed Celecoxib Plasma Concentration | | PK population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No celecoxib PK statistical analyses were performed for the PK participants in the amlodipine+placebo and placebo+placebo arms. | Posted | | Mean | Standard Deviation | log(ng/mL) | | 24 hours post-dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine+Celecoxib | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks | | OG001 | Placebo+Celecoxib | Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks |
| |
| Secondary | Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Secondary Endpoint | | ITT Population as described for primary outcome | Posted | | Mean | Standard Deviation | mmHg | | Baseline and 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine+Celecoxib | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks | | OG001 | Amlodipine+Placebo | Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Over-encapsulated 10 mg amlodipine besylate tablet: Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks Matched placebo capsule for over-encapsulated celecoxib capsule: Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks | | OG002 | Placebo+Celecoxib | Matched placebo tablet for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Over-encapsulated 200 mg celecoxib capsule: Over-encapsulated 200 mg celecoxib capsule once a day for two weeks Matched placebo tablet for over-encapsulated amlodipine besylate tablet: Matched placebo tablet for over-encapsulated amlodipine besylate tablet once a day for two weeks |
|