Trial Outcomes & Findings for The Role of COX-2 Inhibition in Salt Sensitivity of Blood Pressure (NCT NCT00624559)

Results Overview

Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

24 hours

Results posted on

2012-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	Celebrex, High Sodium Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).	Celebrex, Low Sodium 100 mg Celebrex, twice per day for 7 days on low sodium diet	Placebo, Low Sodium Placebo pill taken twice per day over the course of the diet	Placebo, High Sodium Placebo pill taken twice per day over the course of the diet
Overall Study STARTED	3	3	3	3
Overall Study COMPLETED	3	3	3	3
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Role of COX-2 Inhibition in Salt Sensitivity of Blood Pressure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Celebrex, High Sodium n=3 Participants Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).	Celebrex, Low Sodium n=3 Participants 100 mg Celebrex, twice per day for 7 days on low sodium diet	Placebo, Low Sodium n=3 Participants Placebo pill taken twice per day over the course of the diet	Placebo, High Sodium n=3 Participants Placebo pill taken twice per day over the course of the diet	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age Continuous	35 years STANDARD_DEVIATION 2 • n=5 Participants	35 years STANDARD_DEVIATION 2 • n=7 Participants	35 years STANDARD_DEVIATION 2 • n=5 Participants	35 years STANDARD_DEVIATION 2 • n=4 Participants	35 years STANDARD_DEVIATION 2 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	10 Participants n=21 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	12 participants n=21 Participants

PRIMARY outcome

Timeframe: 24 hours

Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor

Outcome measures

Outcome measures
Measure	Celebrex, Low Sodium Diet n=12 Participants Result taken at the end of 7 day low sodium diet	Celebrex, High Sodium Diet n=12 Participants Result taken on last day of a 7 day high salt diet	Placebo, Low Sodium Diet n=12 Participants Blood pressure taken over 24 hours on the last day of the low sodium diet with and ambulatory blood pressure monitor	Placebo, High Sodium Diet n=12 Participants Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet
Mean Arterial Pressure	88 mm Hg Standard Error 2	87 mm Hg Standard Error 2	87 mm Hg Standard Error 2	87 mm Hg Standard Error 2

SECONDARY outcome

Timeframe: 24 hour

Urine collected over 24 hour period on last day of each different sodium diet

Outcome measures

Outcome measures
Measure	Celebrex, Low Sodium Diet n=12 Participants Result taken at the end of 7 day low sodium diet	Celebrex, High Sodium Diet n=12 Participants Result taken on last day of a 7 day high salt diet	Placebo, Low Sodium Diet n=12 Participants Blood pressure taken over 24 hours on the last day of the low sodium diet with and ambulatory blood pressure monitor	Placebo, High Sodium Diet n=12 Participants Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet
Urinary Sodium Excretion	17 mmol Na+/24 hr Standard Error 7	281 mmol Na+/24 hr Standard Error 27	14 mmol Na+/24 hr Standard Error 3	253 mmol Na+/24 hr Standard Error 10

Adverse Events

Celebrex, High Sodium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Celebrex, Low Sodium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo, Low Sodium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo, High Sodium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. William Farquhar

University of Delaware

Phone: 302-831-6178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place