Trial Outcomes & Findings for Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension (NCT NCT00425373)
NCT ID: NCT00425373
Last Updated: 2011-04-29
Results Overview
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1474 participants
Primary outcome timeframe
Baseline to end of study (Week 8)
Results posted on
2011-04-29
Participant Flow
Participant milestones
| Measure |
Valsartan + Amlodipine 40/2.5 mg
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/5 mg
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/2.5 mg
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/5 mg
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 40 mg
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 80 mg
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Amlodipine 2.5 mg
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Amlodipine 5 mg
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Placebo
4 tablet and 2 capsule placebos taken once daily
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
159
|
167
|
160
|
162
|
169
|
163
|
161
|
161
|
166
|
|
Overall Study
COMPLETED
|
154
|
164
|
157
|
160
|
159
|
154
|
154
|
151
|
148
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
3
|
2
|
10
|
9
|
7
|
10
|
18
|
Reasons for withdrawal
| Measure |
Valsartan + Amlodipine 40/2.5 mg
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/5 mg
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/2.5 mg
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/5 mg
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 40 mg
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 80 mg
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Amlodipine 2.5 mg
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Amlodipine 5 mg
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Placebo
4 tablet and 2 capsule placebos taken once daily
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
0
|
1
|
4
|
6
|
2
|
3
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
1
|
4
|
0
|
2
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
3
|
3
|
0
|
5
|
Baseline Characteristics
Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension
Baseline characteristics by cohort
| Measure |
Valsartan + Amlodipine 40/2.5 mg
n=159 Participants
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/5 mg
n=167 Participants
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/2.5 mg
n=160 Participants
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/5 mg
n=162 Participants
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 40 mg
n=169 Participants
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 80 mg
n=163 Participants
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Amlodipine 2.5 mg
n=161 Participants
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Amlodipine 5 mg
n=161 Participants
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Placebo
n=166 Participants
4 tablet and 2 capsule placebos taken once daily
|
Total
n=1468 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
53.9 years
STANDARD_DEVIATION 10.34 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 10.70 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 10.76 • n=5 Participants
|
54.1 years
STANDARD_DEVIATION 9.75 • n=4 Participants
|
52.9 years
STANDARD_DEVIATION 10.08 • n=21 Participants
|
52.6 years
STANDARD_DEVIATION 11.29 • n=10 Participants
|
53.2 years
STANDARD_DEVIATION 10.83 • n=115 Participants
|
54.4 years
STANDARD_DEVIATION 10.67 • n=24 Participants
|
51.5 years
STANDARD_DEVIATION 10.58 • n=42 Participants
|
53.1 years
STANDARD_DEVIATION 10.57 • n=42 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
49 Participants
n=115 Participants
|
40 Participants
n=24 Participants
|
55 Participants
n=42 Participants
|
405 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
131 Participants
n=21 Participants
|
114 Participants
n=10 Participants
|
112 Participants
n=115 Participants
|
121 Participants
n=24 Participants
|
111 Participants
n=42 Participants
|
1063 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Outcome measures
| Measure |
Valsartan + Amlodipine 80/2.5 mg
n=160 Participants
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/5 mg
n=162 Participants
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 40 mg
n=169 Participants
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 80 mg
n=163 Participants
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/2.5 mg
n=159 Participants
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/5 mg
n=167 Participants
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Amlodipine 2.5 mg
n=161 Participants
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Amlodipine 5 mg
n=161 Participants
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Placebo
n=166 Participants
4 tablet and 2 capsule placebos taken once daily
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)
|
-12.6 mm Hg
Standard Error 0.62
|
-17.0 mm Hg
Standard Error 0.61
|
-8.5 mm Hg
Standard Error 0.60
|
-8.8 mm Hg
Standard Error 0.61
|
-13.5 mm Hg
Standard Error 0.62
|
-16.5 mm Hg
Standard Error 0.60
|
-10.3 mm Hg
Standard Error 0.61
|
-13.4 mm Hg
Standard Error 0.61
|
-4.8 mm Hg
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Outcome measures
| Measure |
Valsartan + Amlodipine 80/2.5 mg
n=160 Participants
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/5 mg
n=162 Participants
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 40 mg
n=169 Participants
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 80 mg
n=163 Participants
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/2.5 mg
n=159 Participants
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/5 mg
n=167 Participants
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Amlodipine 2.5 mg
n=161 Participants
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Amlodipine 5 mg
n=161 Participants
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Placebo
n=166 Participants
4 tablet and 2 capsule placebos taken once daily
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)
|
-16.9 mm Hg
Standard Error 0.88
|
-22.9 mm Hg
Standard Error 0.87
|
-9.3 mm Hg
Standard Error 0.85
|
-9.5 mm Hg
Standard Error 0.87
|
-16.7 mm Hg
Standard Error 0.88
|
-22.0 mm Hg
Standard Error 0.86
|
-13.6 mm Hg
Standard Error 0.87
|
-16.6 mm Hg
Standard Error 0.87
|
-4.4 mm Hg
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Outcome measures
| Measure |
Valsartan + Amlodipine 80/2.5 mg
n=160 Participants
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/5 mg
n=162 Participants
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 40 mg
n=169 Participants
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 80 mg
n=163 Participants
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/2.5 mg
n=159 Participants
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/5 mg
n=167 Participants
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Amlodipine 2.5 mg
n=161 Participants
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Amlodipine 5 mg
n=161 Participants
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Placebo
n=166 Participants
4 tablet and 2 capsule placebos taken once daily
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)
|
80.6 Percentage of patients
|
86.4 Percentage of patients
|
52.1 Percentage of patients
|
47.9 Percentage of patients
|
77.4 Percentage of patients
|
88.0 Percentage of patients
|
62.1 Percentage of patients
|
74.5 Percentage of patients
|
36.1 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Outcome measures
| Measure |
Valsartan + Amlodipine 80/2.5 mg
n=160 Participants
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/5 mg
n=162 Participants
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 40 mg
n=169 Participants
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 80 mg
n=163 Participants
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/2.5 mg
n=159 Participants
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/5 mg
n=167 Participants
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Amlodipine 2.5 mg
n=161 Participants
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Amlodipine 5 mg
n=161 Participants
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Placebo
n=166 Participants
4 tablet and 2 capsule placebos taken once daily
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)
|
72.5 Percentage of patients
|
80.9 Percentage of patients
|
46.2 Percentage of patients
|
41.1 Percentage of patients
|
67.3 Percentage of patients
|
82.6 Percentage of patients
|
55.3 Percentage of patients
|
67.1 Percentage of patients
|
31.9 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Outcome measures
| Measure |
Valsartan + Amlodipine 80/2.5 mg
n=160 Participants
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/5 mg
n=162 Participants
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 40 mg
n=169 Participants
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 80 mg
n=163 Participants
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/2.5 mg
n=159 Participants
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/5 mg
n=167 Participants
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Amlodipine 2.5 mg
n=161 Participants
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Amlodipine 5 mg
n=161 Participants
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Placebo
n=166 Participants
4 tablet and 2 capsule placebos taken once daily
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)
|
59.4 Percentage of patients
|
72.2 Percentage of patients
|
33.1 Percentage of patients
|
30.1 Percentage of patients
|
55.3 Percentage of patients
|
75.4 Percentage of patients
|
41.0 Percentage of patients
|
57.1 Percentage of patients
|
18.7 Percentage of patients
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Valsartan 40 mg
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Valsartan 80 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Amlodipine 2.5 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Valsartan + Amlodipine 40/2.5 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Valsartan + Amlodipine 80/2.5 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Amlodipine 5 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Valsartan + Amlodipine 40/5 mg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Valsartan + Amlodipine 80/5 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=166 participants at risk
4 tablet and 2 capsule placebos taken once daily
|
Valsartan 40 mg
n=169 participants at risk
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 80 mg
n=163 participants at risk
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Amlodipine 2.5 mg
n=161 participants at risk
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/2.5 mg
n=159 participants at risk
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/2.5 mg
n=160 participants at risk
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Amlodipine 5 mg
n=161 participants at risk
Amlodipine 2.5 mg 2 capsules plus 4 tablet placebos taken once daily
|
Valsartan + Amlodipine 40/5 mg
n=167 participants at risk
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/5 mg
n=162 participants at risk
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/166
|
0.00%
0/169
|
0.00%
0/163
|
0.62%
1/161
|
0.00%
0/159
|
0.00%
0/160
|
0.00%
0/161
|
0.00%
0/167
|
0.00%
0/162
|
|
Eye disorders
Ulcerative keratitis
|
0.60%
1/166
|
0.00%
0/169
|
0.00%
0/163
|
0.00%
0/161
|
0.00%
0/159
|
0.00%
0/160
|
0.00%
0/161
|
0.00%
0/167
|
0.00%
0/162
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/166
|
0.00%
0/169
|
0.00%
0/163
|
0.00%
0/161
|
0.00%
0/159
|
0.00%
0/160
|
0.00%
0/161
|
0.60%
1/167
|
0.00%
0/162
|
|
Infections and infestations
Pyelonephritis acute
|
0.60%
1/166
|
0.00%
0/169
|
0.00%
0/163
|
0.00%
0/161
|
0.00%
0/159
|
0.00%
0/160
|
0.00%
0/161
|
0.00%
0/167
|
0.00%
0/162
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/166
|
0.00%
0/169
|
0.00%
0/163
|
0.00%
0/161
|
0.00%
0/159
|
0.62%
1/160
|
0.00%
0/161
|
0.00%
0/167
|
0.00%
0/162
|
Other adverse events
| Measure |
Placebo
n=166 participants at risk
4 tablet and 2 capsule placebos taken once daily
|
Valsartan 40 mg
n=169 participants at risk
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan 80 mg
n=163 participants at risk
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Amlodipine 2.5 mg
n=161 participants at risk
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
|
Valsartan + Amlodipine 40/2.5 mg
n=159 participants at risk
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/2.5 mg
n=160 participants at risk
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Amlodipine 5 mg
n=161 participants at risk
Amlodipine 2.5 mg 2 capsules plus 4 tablet placebos taken once daily
|
Valsartan + Amlodipine 40/5 mg
n=167 participants at risk
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
Valsartan + Amlodipine 80/5 mg
n=162 participants at risk
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.2%
17/166
|
13.6%
23/169
|
11.7%
19/163
|
7.5%
12/161
|
10.7%
17/159
|
5.6%
9/160
|
7.5%
12/161
|
12.0%
20/167
|
8.6%
14/162
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER