Trial Outcomes & Findings for Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control (NCT NCT01669928)
NCT ID: NCT01669928
Last Updated: 2021-03-08
Results Overview
Changes in 24 hour systolic Blood Pressure using ABPM
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
103 participants
Primary outcome timeframe
6 months
Results posted on
2021-03-08
Participant Flow
Participant milestones
| Measure |
Morning Medication, Then Evening
Antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months, then cross over to antihypertensive medication in the evening (between 18.00 and 23.00) for 6 months.
Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication.
|
Evening Medication, Then Morning
Anti hypertensive medication in the evening (between 18.00 and 23.00) for 6 months, then cross over to antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months,
Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication.
|
|---|---|---|
|
First Intervention
STARTED
|
51
|
52
|
|
First Intervention
COMPLETED
|
48
|
47
|
|
First Intervention
NOT COMPLETED
|
3
|
5
|
|
Second Intervention
STARTED
|
48
|
47
|
|
Second Intervention
COMPLETED
|
48
|
47
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Morning Medication, Then Evening
Antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months, then cross over to antihypertensive medication in the evening (between 18.00 and 23.00) for 6 months.
Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication.
|
Evening Medication, Then Morning
Anti hypertensive medication in the evening (between 18.00 and 23.00) for 6 months, then cross over to antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months,
Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication.
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
3
|
5
|
Baseline Characteristics
Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control
Baseline characteristics by cohort
| Measure |
Morning Medication, Then Evening
n=51 Participants
Antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months, then cross over to antihypertensive medication in the evening (between 18.00 and 23.00) for 6 months.
Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication.
|
Evening Medication, Then Morning
n=52 Participants
Anti hypertensive medication in the evening (between 18.00 and 23.00) for 6 months, then cross over to antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months,
Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 11 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Total of 8 withdrawals / drop outs
Changes in 24 hour systolic Blood Pressure using ABPM
Outcome measures
| Measure |
Morning Medication
n=95 Participants
Antihypertensive medication in the morning (between 06.00 and 11.00)
|
Evening Medication
n=95 Participants
Anti hypertensive medication in the evening (between 18.00 and 23.00)
|
|---|---|---|
|
Changes in 24 Hour Systolic Blood Pressure
|
129.65 mm Hg
Standard Deviation 10.66
|
129.75 mm Hg
Standard Deviation 12.75
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Total of 8 withdrawals / drop outs
Outcome measures
| Measure |
Morning Medication
n=95 Participants
Antihypertensive medication in the morning (between 06.00 and 11.00)
|
Evening Medication
n=97 Participants
Anti hypertensive medication in the evening (between 18.00 and 23.00)
|
|---|---|---|
|
Mean Day-time ABPM Systolic BP
|
132.24 mm Hg
Standard Deviation 10.86
|
132.77 mm Hg
Standard Deviation 12.87
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Total of 8 withdrawals / drop outs
Outcome measures
| Measure |
Morning Medication
n=95 Participants
Antihypertensive medication in the morning (between 06.00 and 11.00)
|
Evening Medication
n=97 Participants
Anti hypertensive medication in the evening (between 18.00 and 23.00)
|
|---|---|---|
|
Mean Day-time ABPM Diastolic BP
|
79.27 mm Hg
Standard Deviation 7.73
|
80.55 mm Hg
Standard Deviation 8.51
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Total of 8 withdrawals / drop outs
Outcome measures
| Measure |
Morning Medication
n=95 Participants
Antihypertensive medication in the morning (between 06.00 and 11.00)
|
Evening Medication
n=97 Participants
Anti hypertensive medication in the evening (between 18.00 and 23.00)
|
|---|---|---|
|
Μean Night Time ABPM Systolic BP
|
122.76 mm Hg
Standard Error 12.18
|
121.08 mm Hg
Standard Error 14.92
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Total of 8 withdrawals / drop outs
Outcome measures
| Measure |
Morning Medication
n=95 Participants
Antihypertensive medication in the morning (between 06.00 and 11.00)
|
Evening Medication
n=97 Participants
Anti hypertensive medication in the evening (between 18.00 and 23.00)
|
|---|---|---|
|
Μean Night Time ABPM Diastolic BP
|
70.92 mm Hg
Standard Deviation 9.68
|
70.57 mm Hg
Standard Deviation 9.67
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Total of 8 withdrawals / drop outs
This measure was assessed at a clinic.
Outcome measures
| Measure |
Morning Medication
n=95 Participants
Antihypertensive medication in the morning (between 06.00 and 11.00)
|
Evening Medication
n=97 Participants
Anti hypertensive medication in the evening (between 18.00 and 23.00)
|
|---|---|---|
|
Mean Clinic - Systolic BP
|
129.37 mm Hg
Standard Deviation 11.21
|
129.81 mm Hg
Standard Deviation 12.53
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Total of 8 withdrawals / drop outs
This measure was assessed at a clinic.
Outcome measures
| Measure |
Morning Medication
n=95 Participants
Antihypertensive medication in the morning (between 06.00 and 11.00)
|
Evening Medication
n=97 Participants
Anti hypertensive medication in the evening (between 18.00 and 23.00)
|
|---|---|---|
|
Mean Clinic - Diastolic BP
|
77.26 mm Hg
Standard Deviation 7.12
|
77.41 mm Hg
Standard Deviation 8.36
|
SECONDARY outcome
Timeframe: 12 monthsSerious Adverse Events reported during the trial
Outcome measures
| Measure |
Morning Medication
n=95 Participants
Antihypertensive medication in the morning (between 06.00 and 11.00)
|
Evening Medication
n=97 Participants
Anti hypertensive medication in the evening (between 18.00 and 23.00)
|
|---|---|---|
|
Self Reported Side Effects
|
0 Serious Adverse Events
|
3 Serious Adverse Events
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Total of 8 withdrawals / drop outs
Quality of Life Score via questionnaire - EQ-5D-5L Score scale is 0-100, 100 optimal health state.
Outcome measures
| Measure |
Morning Medication
n=95 Participants
Antihypertensive medication in the morning (between 06.00 and 11.00)
|
Evening Medication
n=97 Participants
Anti hypertensive medication in the evening (between 18.00 and 23.00)
|
|---|---|---|
|
Quality of Life Score
|
84.14 Score out of 100
Standard Deviation 11.45
|
84.04 Score out of 100
Standard Deviation 10.25
|
Adverse Events
Morning Medication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Evening Medication
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Morning Medication
n=97 participants at risk；n=95 participants at risk
Antihypertensive medication in the morning (between 06.00 and 11.00)
|
Evening Medication
n=95 participants at risk；n=97 participants at risk
Anti hypertensive medication in the evening (between 18.00 and 23.00)
|
|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/95 • 2 years
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
Planned admission for ERCP with stent.
|
0.00%
0/95 • 2 years
|
1.0%
1/97 • Number of events 1 • 2 years
|
|
Cardiac disorders
Syncope episode
|
0.00%
0/95 • 2 years
|
1.0%
1/97 • Number of events 1 • 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place