Trial Outcomes & Findings for Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension. (NCT NCT00698646)
NCT ID: NCT00698646
Last Updated: 2011-04-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
384 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2011-04-19
Participant Flow
Participant milestones
| Measure |
Valsartan
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
|
HCTZ
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
|
Valsartan + HCTZ
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
|
|---|---|---|---|
|
Overall Study
STARTED
|
128
|
128
|
128
|
|
Overall Study
COMPLETED
|
92
|
97
|
99
|
|
Overall Study
NOT COMPLETED
|
36
|
31
|
29
|
Reasons for withdrawal
| Measure |
Valsartan
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
|
HCTZ
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
|
Valsartan + HCTZ
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
7
|
8
|
|
Overall Study
Unsatisfactory Therapeutic Effect
|
11
|
11
|
7
|
|
Overall Study
Protocol Deviation
|
6
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
10
|
11
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
|
Overall Study
Administrative problems
|
1
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.
Baseline characteristics by cohort
| Measure |
Valsartan
n=128 Participants
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
|
HCTZ
n=128 Participants
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
|
Valsartan + HCTZ
n=128 Participants
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
|
Total
n=384 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
77.7 years
STANDARD_DEVIATION 4.22 • n=5 Participants
|
77.7 years
STANDARD_DEVIATION 4.80 • n=7 Participants
|
77.2 years
STANDARD_DEVIATION 3.99 • n=5 Participants
|
77.5 years
STANDARD_DEVIATION 4.34 • n=4 Participants
|
|
Age, Customized
70-75 years
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
44 participants
n=5 Participants
|
126 participants
n=4 Participants
|
|
Age, Customized
76-80 years
|
60 participants
n=5 Participants
|
56 participants
n=7 Participants
|
65 participants
n=5 Participants
|
181 participants
n=4 Participants
|
|
Age, Customized
>80 years
|
27 participants
n=5 Participants
|
31 participants
n=7 Participants
|
19 participants
n=5 Participants
|
77 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
214 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
170 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Intent to treat (ITT), Last observation carried forward
Outcome measures
| Measure |
Valsartan
n=128 Participants
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
|
HCTZ
n=126 Participants
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
|
Valsartan + HCTZ
n=126 Participants
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
|
|---|---|---|---|
|
Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Baseline
|
166.2 mm Hg
Standard Deviation 11.07
|
164.5 mm Hg
Standard Deviation 11.84
|
164.5 mm Hg
Standard Deviation 11.86
|
|
Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Week 4
|
157.5 mm Hg
Standard Deviation 19.71
|
150.9 mm Hg
Standard Deviation 18.41
|
147.1 mm Hg
Standard Deviation 18.35
|
|
Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Change in MSSBP from Baseline to Week 4
|
-8.6 mm Hg
Standard Deviation 19.47
|
-13.6 mm Hg
Standard Deviation 16.81
|
-17.3 mm Hg
Standard Deviation 17.61
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12 and 16Population: Intent to treat (ITT), Last observation carried forward
Outcome measures
| Measure |
Valsartan
n=128 Participants
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
|
HCTZ
n=126 Participants
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
|
Valsartan + HCTZ
n=126 Participants
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
|
|---|---|---|---|
|
Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
Baseline
|
84.9 mm Hg
Standard Deviation 9.78
|
85.5 mm Hg
Standard Deviation 9.09
|
84.8 mm Hg
Standard Deviation 9.36
|
|
Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
Week 4
|
81.0 mm Hg
Standard Deviation 10.61
|
81.6 mm Hg
Standard Deviation 10.97
|
77.8 mm Hg
Standard Deviation 9.66
|
|
Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
Change in MSDBP from Baseline to Week 4
|
-3.9 mm Hg
Standard Deviation 9.08
|
-3.9 mm Hg
Standard Deviation 10.24
|
-7.1 mm Hg
Standard Deviation 8.80
|
|
Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
Week 8
|
78.3 mm Hg
Standard Deviation 10.33
|
79.1 mm Hg
Standard Deviation 11.97
|
76.5 mm Hg
Standard Deviation 9.45
|
|
Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
Change in MSDBP from Baseline to Week 8
|
-6.6 mm Hg
Standard Deviation 10.26
|
-6.4 mm Hg
Standard Deviation 10.72
|
-8.4 mm Hg
Standard Deviation 9.68
|
|
Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
Week 12
|
77.6 mm Hg
Standard Deviation 11.0
|
78.1 mm Hg
Standard Deviation 11.42
|
75.4 mm Hg
Standard Deviation 8.87
|
|
Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
Change in MSDBP from Baseline to Week 12
|
-7.3 mm Hg
Standard Deviation 10.55
|
-7.3 mm Hg
Standard Deviation 10.75
|
-9.5 mm Hg
Standard Deviation 9.66
|
|
Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
Week 16
|
77.8 mm Hg
Standard Deviation 10.34
|
77.9 mm Hg
Standard Deviation 11.66
|
76.6 mm Hg
Standard Deviation 8.42
|
|
Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
Change in MSDBP from Baseline to Week 16
|
-7.1 mm Hg
Standard Deviation 10.78
|
-7.5 mm Hg
Standard Deviation 10.76
|
-8.3 mm Hg
Standard Deviation 8.62
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8, 12, and 16Population: Intent to treat (ITT), Last observation carried forward
Outcome measures
| Measure |
Valsartan
n=128 Participants
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
|
HCTZ
n=126 Participants
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
|
Valsartan + HCTZ
n=126 Participants
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
|
|---|---|---|---|
|
Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Baseline
|
166.2 mm Hg
Standard Deviation 11.07
|
164.5 mm Hg
Standard Deviation 11.84
|
164.5 mm Hg
Standard Deviation 11.86
|
|
Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Week 8
|
150.4 mm Hg
Standard Deviation 20.29
|
147.4 mm Hg
Standard Deviation 18.69
|
144.2 mm Hg
Standard Deviation 19.93
|
|
Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Change in MSSBP from Baseline to Week 8
|
-15.7 mm Hg
Standard Deviation 20.43
|
-17.1 mm Hg
Standard Deviation 17.83
|
-20.2 mm Hg
Standard Deviation 19.12
|
|
Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Week 12
|
148.6 mm Hg
Standard Deviation 21.45
|
145.1 mm Hg
Standard Deviation 19.38
|
142.0 mm Hg
Standard Deviation 18.78
|
|
Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Change in MSSBP from Baseline to Week 12
|
-17.5 mm Hg
Standard Deviation 21.16
|
-19.4 mm Hg
Standard Deviation 19.19
|
-22.5 mm Hg
Standard Deviation 19.52
|
|
Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Week 16
|
148.7 mm Hg
Standard Deviation 20.06
|
144.9 mm Hg
Standard Deviation 19.59
|
143.5 mm Hg
Standard Deviation 18.69
|
|
Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Change in MSSBP from Baseline to Week 16
|
-17.5 mm Hg
Standard Deviation 19.62
|
-19.7 mm Hg
Standard Deviation 19.69
|
-20.9 mm Hg
Standard Deviation 18.49
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12 and 16Population: Intent to treat (ITT)
Cumulative refers to achieving of blood pressure control before or at the corresponding visit.
Outcome measures
| Measure |
Valsartan
n=128 Participants
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
|
HCTZ
n=126 Participants
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
|
Valsartan + HCTZ
n=126 Participants
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
|
|---|---|---|---|
|
Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg
Week 4
|
25 Percentage of Participants
|
37.3 Percentage of Participants
|
49.21 Percentage of Participants
|
|
Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg
Week 8
|
40.63 Percentage of Participants
|
50.79 Percentage of Participants
|
63.49 Percentage of Participants
|
|
Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg
Week 12
|
50 Percentage of Participants
|
61.11 Percentage of Participants
|
69.05 Percentage of Participants
|
|
Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg
Week 16
|
55.47 Percentage of Participants
|
66.67 Percentage of Participants
|
72.22 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12 and 16Population: Intent to treat (ITT)
Cumulative refers to achieving blood pressure goal before or at the corresponding visit.
Outcome measures
| Measure |
Valsartan
n=128 Participants
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
|
HCTZ
n=126 Participants
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
|
Valsartan + HCTZ
n=126 Participants
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
|
|---|---|---|---|
|
Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)
Week 16
|
56.25 Percentage of Participants
|
68.25 Percentage of Participants
|
72.22 Percentage of Participants
|
|
Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)
Week 4
|
25 Percentage of Participants
|
38.89 Percentage of Participants
|
49.21 Percentage of Participants
|
|
Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)
Week 8
|
40.63 Percentage of Participants
|
52.38 Percentage of Participants
|
63.49 Percentage of Participants
|
|
Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)
Week 12
|
50 Percentage of Participants
|
62.70 Percentage of Participants
|
69.05 Percentage of Participants
|
SECONDARY outcome
Timeframe: During 16 weeksPopulation: Intent to treat (ITT)
Outcome measures
| Measure |
Valsartan
n=128 Participants
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
|
HCTZ
n=126 Participants
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
|
Valsartan + HCTZ
n=126 Participants
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
|
|---|---|---|---|
|
Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])
|
12.0 Weeks
Interval 8.0 to 12.0
|
8.0 Weeks
Interval 7.0 to 12.0
|
4.0 Weeks
Interval 3.0 to 8.0
|
Adverse Events
Valsartan + HCTZ
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
HCTZ
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Valsartan
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valsartan + HCTZ
n=128 participants at risk
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
|
HCTZ
n=128 participants at risk
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
|
Valsartan
n=128 participants at risk
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/128 • 16 weeks
|
0.78%
1/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
0.78%
1/128 • 16 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
0.78%
1/128 • 16 weeks
|
|
Infections and infestations
Pneumonia
|
0.78%
1/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
0.78%
1/128 • 16 weeks
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
0.78%
1/128 • 16 weeks
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/128 • 16 weeks
|
0.78%
1/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.78%
1/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
0.78%
1/128 • 16 weeks
|
|
Nervous system disorders
Syncope
|
0.78%
1/128 • 16 weeks
|
0.78%
1/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/128 • 16 weeks
|
0.78%
1/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.78%
1/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
|
Vascular disorders
Hypotension
|
0.78%
1/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
0.00%
0/128 • 16 weeks
|
Other adverse events
| Measure |
Valsartan + HCTZ
n=128 participants at risk
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
|
HCTZ
n=128 participants at risk
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
|
Valsartan
n=128 participants at risk
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
|
|---|---|---|---|
|
General disorders
Fatigue
|
3.9%
5/128 • 16 weeks
|
7.8%
10/128 • 16 weeks
|
3.9%
5/128 • 16 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.78%
1/128 • 16 weeks
|
3.1%
4/128 • 16 weeks
|
6.2%
8/128 • 16 weeks
|
|
Nervous system disorders
Dizziness
|
3.9%
5/128 • 16 weeks
|
6.2%
8/128 • 16 weeks
|
7.0%
9/128 • 16 weeks
|
|
Nervous system disorders
Headache
|
4.7%
6/128 • 16 weeks
|
7.0%
9/128 • 16 weeks
|
2.3%
3/128 • 16 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