Trial Outcomes & Findings for The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy (NCT NCT00666536)
NCT ID: NCT00666536
Last Updated: 2016-10-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
728 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2016-10-27
Participant Flow
369 and 359 are the total randomized patients by treatment groups respectively. In the baseline measures tables 366 and 357 are the total patients for the ITT population by treatment group.
Participant milestones
| Measure |
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
Moderate Treatment Regimen (5/160 mg)
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
369
|
359
|
|
Overall Study
COMPLETED
|
336
|
322
|
|
Overall Study
NOT COMPLETED
|
33
|
37
|
Reasons for withdrawal
| Measure |
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
Moderate Treatment Regimen (5/160 mg)
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
19
|
|
Overall Study
Unsatisfactory therapeutic effect
|
2
|
0
|
|
Overall Study
Protocol deviation(s)
|
8
|
6
|
|
Overall Study
Withdrawal by Subject
|
10
|
9
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
Baseline Characteristics
The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy
Baseline characteristics by cohort
| Measure |
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)
n=366 Participants
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
Moderate Treatment Regimen (5/160 mg)
n=357 Participants
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
Total
n=723 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
302 participants
n=5 Participants
|
292 participants
n=7 Participants
|
594 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
64 participants
n=5 Participants
|
65 participants
n=7 Participants
|
129 participants
n=5 Participants
|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 10.98 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
209 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
409 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Intent to treat (ITT), Last observation carried forward (LOCF)
Outcome measures
| Measure |
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)
n=366 Participants
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
Moderate Treatment Regimen (5/160 mg)
n=357 Participants
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
|---|---|---|
|
Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)
Baseline MSSBP
|
163.9 mmHg
Standard Deviation 11.85
|
163.3 mmHg
Standard Deviation 11.40
|
|
Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)
Week 4 MSSBP
|
140.9 mmHg
Standard Deviation 14.61
|
144.4 mmHg
Standard Deviation 14.21
|
|
Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)
Change From Baseline to Week 4 in MSSBP
|
-23.0 mmHg
Standard Deviation 14.60
|
-18.9 mmHg
Standard Deviation 13.92
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8 and 12Population: Intent to treat (ITT), Last observation carried forward (LOCF)
Outcome measures
| Measure |
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)
n=366 Participants
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
Moderate Treatment Regimen (5/160 mg)
n=357 Participants
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
|---|---|---|
|
Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12
Week 2
|
25.1 Percentage of Patients
|
25.8 Percentage of Patients
|
|
Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12
Week 4
|
43.7 Percentage of Patients
|
31.1 Percentage of Patients
|
|
Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12
Week 8
|
61.7 Percentage of Patients
|
46.2 Percentage of Patients
|
|
Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12
Week 12
|
59.8 Percentage of Patients
|
50.7 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Intent to treat (ITT), Last observation carried forward (LOCF)
Outcome measures
| Measure |
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)
n=366 Participants
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
Moderate Treatment Regimen (5/160 mg)
n=357 Participants
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
|---|---|---|
|
Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)
Baseline MSDBP
|
95.5 mmHg
Standard Deviation 11.19
|
95.0 mmHg
Standard Deviation 10.33
|
|
Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)
Week 4 MSDBP
|
84.8 mmHg
Standard Deviation 11.47
|
86.2 mmHg
Standard Deviation 9.6
|
|
Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)
Change From Baseline to Week 4 in MSDBP
|
-10.7 mmHg
Standard Deviation 9.39
|
-8.8 mmHg
Standard Deviation 9.08
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 8 and 12Population: Intent to treat (ITT), Last observation carried forward (LOCF)
Outcome measures
| Measure |
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)
n=366 Participants
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
Moderate Treatment Regimen (5/160 mg)
n=357 Participants
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
|---|---|---|
|
Change From Baseline to Weeks 2, 8 and 12 in MSSBP
Baseline MSSBP
|
163.9 mmHg
Standard Deviation 11.85
|
163.3 mmHg
Standard Deviation 11.40
|
|
Change From Baseline to Weeks 2, 8 and 12 in MSSBP
Week 2 MSSBP
|
147.0 mmHg
Standard Deviation 14.93
|
146.0 mmHg
Standard Deviation 14.80
|
|
Change From Baseline to Weeks 2, 8 and 12 in MSSBP
Change From Baseline to Week 2 in MSSBP
|
-16.9 mmHg
Standard Deviation 13.94
|
-17.3 mmHg
Standard Deviation 13.80
|
|
Change From Baseline to Weeks 2, 8 and 12 in MSSBP
Week 8 MSSBP
|
136.0 mmHg
Standard Deviation 15.27
|
140.5 mmHg
Standard Deviation 15.91
|
|
Change From Baseline to Weeks 2, 8 and 12 in MSSBP
Change From Baseline to Week 8 in MSSBP
|
-27.9 mmHg
Standard Deviation 16.08
|
-22.8 mmHg
Standard Deviation 16.15
|
|
Change From Baseline to Weeks 2, 8 and 12 in MSSBP
Week 12 MSSBP
|
135.7 mmHg
Standard Deviation 14.97
|
139.2 mmHg
Standard Deviation 15.63
|
|
Change From Baseline to Weeks 2, 8 and 12 in MSSBP
Change From Baseline to Week 12 in MSSBP
|
-28.1 mmHg
Standard Deviation 16.59
|
-24.1 mmHg
Standard Deviation 16.07
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 8 and 12Population: Intent to treat (ITT), Last observation carried forward (LOCF)
Outcome measures
| Measure |
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)
n=366 Participants
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
Moderate Treatment Regimen (5/160 mg)
n=357 Participants
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
|---|---|---|
|
Change From Baseline to Weeks 2, 8 and 12 in MSDBP
Baseline MSDBP
|
95.5 mmHg
Standard Deviation 11.19
|
95.0 mmHg
Standard Deviation 10.33
|
|
Change From Baseline to Weeks 2, 8 and 12 in MSDBP
Week 2 MSDBP
|
88.2 mmHg
Standard Deviation 10.93
|
87.1 mmHg
Standard Deviation 10.38
|
|
Change From Baseline to Weeks 2, 8 and 12 in MSDBP
Change From Baseline to Week 2 in MSDBP
|
-7.3 mmHg
Standard Deviation 8.51
|
-7.9 mmHg
Standard Deviation 9.66
|
|
Change From Baseline to Weeks 2, 8 and 12 in MSDBP
Week 8 MSDBP
|
81.6 mmHg
Standard Deviation 11.15
|
84.0 mmHg
Standard Deviation 11.39
|
|
Change From Baseline to Weeks 2, 8 and 12 in MSDBP
Change From Baseline to Week 8 in MSDBP
|
-13.9 mmHg
Standard Deviation 9.97
|
-11.0 mmHg
Standard Deviation 10.33
|
|
Change From Baseline to Weeks 2, 8 and 12 in MSDBP
Week 12 MSDBP
|
81.5 mmHg
Standard Deviation 10.62
|
83.8 mmHg
Standard Deviation 10.61
|
|
Change From Baseline to Weeks 2, 8 and 12 in MSDBP
Change From Baseline to Week 12 in MSDBP
|
-14.0 mmHg
Standard Deviation 10.41
|
-11.2 mmHg
Standard Deviation 10.48
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8 and 12Population: Intent to treat (ITT), Last observation carried forward (LOCF)
Outcome measures
| Measure |
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)
n=366 Participants
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
Moderate Treatment Regimen (5/160 mg)
n=357 Participants
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
|---|---|---|
|
Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12
Week 2
|
31.1 Percentage of Patients
|
32.5 Percentage of Patients
|
|
Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12
Week 4
|
49.2 Percentage of Patients
|
37.5 Percentage of Patients
|
|
Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12
Week 8
|
66.1 Percentage of Patients
|
49.6 Percentage of Patients
|
|
Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12
Week 12
|
62.8 Percentage of Patients
|
55.7 Percentage of Patients
|
Adverse Events
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)
Serious events: 4 serious events
Other events: 50 other events
Deaths: 0 deaths
Moderate Treatment Regimen (5/160 mg)
Serious events: 10 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)
n=369 participants at risk
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
Moderate Treatment Regimen (5/160 mg)
n=359 participants at risk
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/369 • 12 weeks
|
0.56%
2/359 • 12 weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/369 • 12 weeks
|
0.56%
2/359 • 12 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/369 • 12 weeks
|
0.56%
2/359 • 12 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
General disorders
Chest pain
|
0.27%
1/369 • 12 weeks
|
0.00%
0/359 • 12 weeks
|
|
General disorders
Gait disturbance
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.27%
1/369 • 12 weeks
|
0.00%
0/359 • 12 weeks
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.27%
1/369 • 12 weeks
|
0.00%
0/359 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.27%
1/369 • 12 weeks
|
0.00%
0/359 • 12 weeks
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Psychiatric disorders
Depression
|
0.27%
1/369 • 12 weeks
|
0.00%
0/359 • 12 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.27%
1/369 • 12 weeks
|
0.00%
0/359 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/369 • 12 weeks
|
0.28%
1/359 • 12 weeks
|
Other adverse events
| Measure |
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)
n=369 participants at risk
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
Moderate Treatment Regimen (5/160 mg)
n=359 participants at risk
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
|
|---|---|---|
|
General disorders
Oedema peripheral
|
8.7%
32/369 • 12 weeks
|
4.5%
16/359 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
5.1%
19/369 • 12 weeks
|
3.9%
14/359 • 12 weeks
|
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