Trial Outcomes & Findings for Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial (NCT NCT01030458)
NCT ID: NCT01030458
Last Updated: 2013-12-09
Results Overview
Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
183 participants
Primary outcome timeframe
6 months follow-up after randomization
Results posted on
2013-12-09
Participant Flow
Participant milestones
| Measure |
Amlodipine Plus Valsartan
In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and to achieve blood pressure control, the study medication could be up-titrated to amlodipine 10 mg plus 160 mg valsartan. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
|
Hydrochlorothiazide Plus Bisoprolol
In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg and to achieve blood pressure control, the study medication could be up-titrated to 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
89
|
|
Overall Study
COMPLETED
|
67
|
57
|
|
Overall Study
NOT COMPLETED
|
27
|
32
|
Reasons for withdrawal
| Measure |
Amlodipine Plus Valsartan
In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and to achieve blood pressure control, the study medication could be up-titrated to amlodipine 10 mg plus 160 mg valsartan. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
|
Hydrochlorothiazide Plus Bisoprolol
In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg and to achieve blood pressure control, the study medication could be up-titrated to 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
10
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Logistical reasons
|
9
|
5
|
|
Overall Study
Moved or changed job
|
6
|
13
|
|
Overall Study
Side effect of medication
|
1
|
1
|
Baseline Characteristics
Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial
Baseline characteristics by cohort
| Measure |
Amlodipine Plus Valsartan
n=94 Participants
In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
|
Hydrochlorothiazide Plus Bisoprolol
n=89 Participants
In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
|
Total
n=183 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
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age Continuous
|
51.3 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
51.2 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
51.2 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Region of Enrollment
Nigeria
|
46 participants
n=5 Participants
|
46 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Region of Enrollment
Senegal
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Gabon
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Cameroon
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months follow-up after randomizationPopulation: The main analysis included all randomised patients with at least one follow-up visit, according to the intention-to-treat principle.
Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome.
Outcome measures
| Measure |
Amlodipine Plus Valsartan
n=94 Participants
In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
|
Hydrochlorothiazide Plus Bisoprolol
n=89 Participants
In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
|
|---|---|---|
|
Sitting Systolic Blood Pressure on Automated Measurement
|
127.2 mmHg
Standard Deviation 10.7
|
134.1 mmHg
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: 6 months follow-up after randomizationThe time (in weeks) after randomisation that will be required to reach and maintain the target, defined as a blood pressure below 140 mmHg systolic and 90 mmHg diastolic.
Outcome measures
| Measure |
Amlodipine Plus Valsartan
n=94 Participants
In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
|
Hydrochlorothiazide Plus Bisoprolol
n=89 Participants
In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
|
|---|---|---|
|
Time to Blood Pressure Control
|
12 weeks
Interval 4.0 to 20.0
|
18 weeks
Interval 4.0 to 24.0
|
SECONDARY outcome
Timeframe: 6 months follow-up after randomizationOutcome measures
| Measure |
Amlodipine Plus Valsartan
n=94 Participants
In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
|
Hydrochlorothiazide Plus Bisoprolol
n=89 Participants
In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
|
|---|---|---|
|
Side-effects to Study Medications
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 months follow-up after randomizationThis variable gives the proportion of patients reaching blood pressure control over time (\< 140 mmHg systolic and \< 90 mmHg diastolic)
Outcome measures
| Measure |
Amlodipine Plus Valsartan
n=94 Participants
In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
|
Hydrochlorothiazide Plus Bisoprolol
n=89 Participants
In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
|
|---|---|---|
|
Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up
|
58 participants
Interval 4.0 to 20.0
|
40 participants
Interval 4.0 to 24.0
|
Adverse Events
Amlodipine Plus Valsartan
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Hydrochlorothiazide Plus Bisoprolol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amlodipine Plus Valsartan
n=94 participants at risk
In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
|
Hydrochlorothiazide Plus Bisoprolol
n=89 participants at risk
In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
|
|---|---|---|
|
Nervous system disorders
Insomnia/asthenia
|
0.00%
0/94
|
1.1%
1/89 • Number of events 1
|
|
General disorders
Bilateral leg oedema
|
1.1%
1/94 • Number of events 1
|
0.00%
0/89
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place