Trial Outcomes & Findings for The Effects of Systolic Blood Pressure Lowering on Diastolic Function Using Valsartan + Amlodipine in Patients With Hypertension and Diastolic Dysfunction (NCT NCT00523549)
NCT ID: NCT00523549
Last Updated: 2012-04-23
Results Overview
Change from baseline in lateral mitral annular myocardial relaxation velocity (E') at Week 24
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
229 participants
Primary outcome timeframe
Baseline to 24 weeks after treatment
Results posted on
2012-04-23
Participant Flow
Participant milestones
| Measure |
Intensive Treatment Regimen
(Valsartan + Amlodipine to target SBP \< 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP \< 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target \< 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target \< 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.
|
Standard Treatment Regimen
(Valsartan + Amlodipine to target SBP of \< 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of \< 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. Patients not at SBP target \< 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
115
|
|
Overall Study
COMPLETED
|
95
|
99
|
|
Overall Study
NOT COMPLETED
|
19
|
16
|
Reasons for withdrawal
| Measure |
Intensive Treatment Regimen
(Valsartan + Amlodipine to target SBP \< 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP \< 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target \< 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target \< 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.
|
Standard Treatment Regimen
(Valsartan + Amlodipine to target SBP of \< 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of \< 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. Patients not at SBP target \< 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
|
Overall Study
Unsatisfactory therapeutic effect
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
3
|
1
|
|
Overall Study
Patient withdrew consent
|
7
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
Baseline Characteristics
The Effects of Systolic Blood Pressure Lowering on Diastolic Function Using Valsartan + Amlodipine in Patients With Hypertension and Diastolic Dysfunction
Baseline characteristics by cohort
| Measure |
Intensive Treatment Regimen
n=114 Participants
(Valsartan + Amlodipine to target SBP \< 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP \< 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target \< 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target \< 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.
|
Standard Treatment Regimen
n=114 Participants
(Valsartan + Amlodipine to target SBP of \< 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of \< 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. Patients not at SBP target \< 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.2 years
STANDARD_DEVIATION 10.03 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 9.45 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 9.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 weeks after treatmentPopulation: Intent-to-treat
Change from baseline in lateral mitral annular myocardial relaxation velocity (E') at Week 24
Outcome measures
| Measure |
Intensive Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP \< 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP \< 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target \< 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target \< 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.
|
Standard Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP of \< 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of \< 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. Patients not at SBP target \< 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.
|
|---|---|---|
|
Change in Lateral Mitral Annular Myocardial Relaxation Velocity
|
1.544 cm/s
Standard Deviation 1.3946
|
1.476 cm/s
Standard Deviation 1.5985
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks after treatmentPopulation: Intent-to-treat
Change from baseline in left atrial size at Week 24
Outcome measures
| Measure |
Intensive Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP \< 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP \< 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target \< 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target \< 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.
|
Standard Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP of \< 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of \< 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. Patients not at SBP target \< 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.
|
|---|---|---|
|
Change in Left Atrial Size
|
-0.127 cm
Standard Deviation 0.3082
|
-0.104 cm
Standard Deviation 0.2845
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks after treatmentPopulation: Intent-to-treat
Change from baseline in peak E-wave velocity / lateral mitral annular myocardial relaxation velocity (E/E') at Week 24
Outcome measures
| Measure |
Intensive Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP \< 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP \< 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target \< 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target \< 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.
|
Standard Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP of \< 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of \< 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. Patients not at SBP target \< 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.
|
|---|---|---|
|
Change in Ratio of Peak E Wave Velocity/Lateral Mitral Annular Myocardial Relaxation Velocity
|
-0.951 ratio
Standard Deviation 2.1729
|
-0.680 ratio
Standard Deviation 2.0714
|
SECONDARY outcome
Timeframe: Baseline to 8 and 24 weeks after treatmentPopulation: Intent-to-treat
Percent change from baseline in Vascular Stiffness (measured by radial augmentation index \[AI\]) at Weeks 8 and 24
Outcome measures
| Measure |
Intensive Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP \< 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP \< 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target \< 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target \< 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.
|
Standard Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP of \< 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of \< 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. Patients not at SBP target \< 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.
|
|---|---|---|
|
Percent Change From Baseline in Vascular Stiffness
Week 24
|
-6.07 percentage of change in mean AI
Standard Deviation 10.582
|
-5.63 percentage of change in mean AI
Standard Deviation 11.367
|
|
Percent Change From Baseline in Vascular Stiffness
Week 8
|
-7.89 percentage of change in mean AI
Standard Deviation 9.645
|
-7.32 percentage of change in mean AI
Standard Deviation 11.970
|
SECONDARY outcome
Timeframe: Baseline to 8 and 24 weeks after treatmentPopulation: Intent-to-treat
Change from baseline in msSBP at Weeks 8 and 24
Outcome measures
| Measure |
Intensive Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP \< 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP \< 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target \< 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target \< 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.
|
Standard Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP of \< 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of \< 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. Patients not at SBP target \< 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.
|
|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (msSBP)
Week 8
|
-25.74 mm Hg
Standard Deviation 16.112
|
-22.31 mm Hg
Standard Deviation 16.014
|
|
Change in Mean Sitting Systolic Blood Pressure (msSBP)
Week 24
|
-30.37 mm Hg
Standard Deviation 18.745
|
-25.06 mm Hg
Standard Deviation 17.074
|
SECONDARY outcome
Timeframe: Baseline to 8 and 24 weeks after treatmentPopulation: Intent-to-treat population
Change from baseline in msDBP at Weeks 8 and 24
Outcome measures
| Measure |
Intensive Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP \< 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP \< 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target \< 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target \< 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.
|
Standard Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP of \< 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of \< 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. Patients not at SBP target \< 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.
|
|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Week 8
|
-12.77 mm Hg
Standard Deviation 10.118
|
-12.62 mm Hg
Standard Deviation 10.475
|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Week 24
|
-15.21 mm Hg
Standard Deviation 10.147
|
-14.08 mm Hg
Standard Deviation 11.163
|
SECONDARY outcome
Timeframe: Baseline to 8 and 24 weeks after treatmentPopulation: Intent-to-treat
Change from baseline in estimated central aortic pressure at Weeks 8 and 24
Outcome measures
| Measure |
Intensive Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP \< 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP \< 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target \< 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target \< 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.
|
Standard Treatment Regimen
n=98 Participants
(Valsartan + Amlodipine to target SBP of \< 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of \< 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. Patients not at SBP target \< 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.
|
|---|---|---|
|
Change in Estimated Central Aortic Pressure
Week 8
|
-16.30 mm Hg
Standard Deviation 12.483
|
-14.68 mm Hg
Standard Deviation 12.751
|
|
Change in Estimated Central Aortic Pressure
Week 24
|
-17.71 mm Hg
Standard Deviation 14.635
|
-14.76 mm Hg
Standard Deviation 12.689
|
Adverse Events
Intensive Treatment Regimen
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Standard Treatment Regimen
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intensive Treatment Regimen
n=114 participants at risk
(Valsartan + Amlodipine to target SBP \< 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP \< 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target \< 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target \< 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.
|
Standard Treatment Regimen
n=114 participants at risk
(Valsartan + Amlodipine to target SBP of \< 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of \< 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. Patients not at SBP target \< 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.88%
1/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
0.00%
0/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Endocrine disorders
Goitre
|
0.88%
1/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
0.00%
0/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
0.88%
1/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
0.88%
1/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
0.88%
1/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
0.88%
1/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
0.88%
1/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
0.88%
1/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.88%
1/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
0.00%
0/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.88%
1/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
0.00%
0/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Nervous system disorders
Dizziness
|
0.88%
1/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
0.00%
0/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
Other adverse events
| Measure |
Intensive Treatment Regimen
n=114 participants at risk
(Valsartan + Amlodipine to target SBP \< 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP \< 130 mm Hg.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target \< 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator's discretion. Patients not at SBP target \< 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.
|
Standard Treatment Regimen
n=114 participants at risk
(Valsartan + Amlodipine to target SBP of \< 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of \< 140 mm Hg was achieved.
At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target \< 140 mm Hg. Patients not at SBP target \< 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.
|
|---|---|---|
|
General disorders
Fatigue
|
10.5%
12/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
6.1%
7/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
General disorders
Oedema peripheral
|
21.1%
24/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
17.5%
20/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
8/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
6.1%
7/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
6/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
3.5%
4/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Nervous system disorders
Dizziness
|
14.0%
16/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
7.9%
9/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
|
Nervous system disorders
Headache
|
4.4%
5/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
7.0%
8/114 • 24 weeks
Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
|
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