Trial Outcomes & Findings for Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension (NCT NCT00446511)
NCT ID: NCT00446511
Last Updated: 2011-07-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
250 participants
Primary outcome timeframe
Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)
Results posted on
2011-07-12
Participant Flow
Participant milestones
| Measure |
CKD Patients: Valsartan+Enalapril
Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
CKD Patients: Enalapril
Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Valsartan
Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Enalapril
Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
17
|
103
|
109
|
|
Overall Study
COMPLETED
|
11
|
15
|
96
|
103
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
7
|
6
|
Reasons for withdrawal
| Measure |
CKD Patients: Valsartan+Enalapril
Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
CKD Patients: Enalapril
Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Valsartan
Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Enalapril
Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
2
|
3
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
|
Overall Study
Administrative Problems
|
3
|
0
|
4
|
1
|
Baseline Characteristics
Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
Baseline characteristics by cohort
| Measure |
CKD Patients: Valsartan+Enalapril
n=21 Participants
Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
CKD Patients: Enalapril
n=17 Participants
Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Valsartan
n=103 Participants
Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Enalapril
n=109 Participants
Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
11.4 years
STANDARD_DEVIATION 3.40 • n=93 Participants
|
12.1 years
STANDARD_DEVIATION 3.07 • n=4 Participants
|
13.1 years
STANDARD_DEVIATION 2.75 • n=27 Participants
|
13.3 years
STANDARD_DEVIATION 2.81 • n=483 Participants
|
13.0 years
STANDARD_DEVIATION 2.89 • n=36 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
81 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
82 Participants
n=483 Participants
|
169 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)Population: Extension safety population
Outcome measures
| Measure |
CKD Patients: Valsartan+Enalapril
n=21 Participants
Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
CKD Patients: Enalapril
n=17 Participants
Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Valsartan
n=103 Participants
Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Enalapril
n=109 Participants
Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
|---|---|---|---|---|
|
Number of Patients With Adverse Events
|
16 Participants
|
11 Participants
|
51 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Core Baseline (Week 0) to Week 26Population: Extension ITT population: All patients that had both baseline and at least 1 post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic BP) during the extension. Baseline is the Week 0 value. Extension endpoint is the Week 26 or last observation after the core endpoint but before Week 26 carried forward value.
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.
Outcome measures
| Measure |
CKD Patients: Valsartan+Enalapril
n=21 Participants
Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
CKD Patients: Enalapril
n=17 Participants
Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Valsartan
n=103 Participants
Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Enalapril
n=108 Participants
Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
|---|---|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26
|
-20.4 mmHg
Standard Deviation 11.48
|
-11.7 mmHg
Standard Deviation 9.55
|
-7.5 mmHg
Standard Deviation 8.47
|
-7.2 mmHg
Standard Deviation 8.99
|
SECONDARY outcome
Timeframe: Week 26Population: The extension ITT population consisted of all extension patients that had both baseline and at least one post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic blood pressure) during the extension. Patients were analyzed according to the treatment they were assigned to at the beginning of their extension.
Systolic and diastolic blood pressure (BP) control was defined as msSBP and msDBP \< 95th percentile for gender, age, and height. After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.
Outcome measures
| Measure |
CKD Patients: Valsartan+Enalapril
n=103 Participants
Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
CKD Patients: Enalapril
n=108 Participants
Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Valsartan
Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Enalapril
Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
|---|---|---|---|---|
|
Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26
Systolic BP control
|
66.0 Percentage of patients
|
63.0 Percentage of patients
|
—
|
—
|
|
Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26
Diastolic BP control
|
95.1 Percentage of patients
|
91.7 Percentage of patients
|
—
|
—
|
SECONDARY outcome
Timeframe: Core Baseline (Week 0) to Week 20Population: ABPM population: All ITT patients who received the 24-hour ambulatory blood pressure monitoring (ABPM) measurements at both baseline and Week 20. Patients were excluded if their baseline ABPM was measured after active treatment dose (considered invalid baseline).
24-hour ambulatory blood pressure monitoring (ABPM) was conducted once during the extension in a subset of patients at selected centers. For all patients who completed a qualifying ABPM at baseline, an ABPM was to be performed at Week 20. The ABPM monitor was placed on the non-dominant arm.
Outcome measures
| Measure |
CKD Patients: Valsartan+Enalapril
n=5 Participants
Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
CKD Patients: Enalapril
n=2 Participants
Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Valsartan
n=10 Participants
Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Enalapril
n=21 Participants
Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
|---|---|---|---|---|
|
Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20
Systolic BP
|
-23.3 mmHg
Standard Deviation 11.60
|
-0.3 mmHg
Standard Deviation 14.42
|
-11.5 mmHg
Standard Deviation 7.81
|
-4.1 mmHg
Standard Deviation 11.49
|
|
Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20
Diastolic BP
|
-17.8 mmHg
Standard Deviation 3.20
|
2.9 mmHg
Standard Deviation 10.81
|
-12.2 mmHg
Standard Deviation 6.60
|
-4.5 mmHg
Standard Deviation 7.59
|
SECONDARY outcome
Timeframe: Core Baseline (Week 0) to Week 26Population: Extension ITT population: All patients that had both baseline and at least 1 post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic BP) during the extension. Baseline is the Week 0 value. Extension endpoint is the Week 26 or last observation after the core endpoint but before Week 26 carried forward value.
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.
Outcome measures
| Measure |
CKD Patients: Valsartan+Enalapril
n=21 Participants
Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
CKD Patients: Enalapril
n=17 Participants
Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Valsartan
n=103 Participants
Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Enalapril
n=108 Participants
Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
|---|---|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26
|
-23.6 mmHg
Standard Deviation 10.79
|
-18.2 mmHg
Standard Deviation 9.51
|
-11.6 mmHg
Standard Deviation 9.74
|
-10.2 mmHg
Standard Deviation 9.70
|
Adverse Events
CKD Patients: Valsartan+Enalapril
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Non-CKD Patients: Valsartan
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
CKD Patients: Enalapril
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Non-CKD Patients: Enalapril
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CKD Patients: Valsartan+Enalapril
n=21 participants at risk
Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Valsartan
n=103 participants at risk
Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
CKD Patients: Enalapril
n=17 participants at risk
Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Enalapril
n=109 participants at risk
Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Adrenogenital syndrome
|
0.00%
0/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.97%
1/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Immune system disorders
Kidney transplant rejection
|
4.8%
1/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.92%
1/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Infections and infestations
Pyelonephritis
|
4.8%
1/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Investigations
White blood cell count decreased
|
4.8%
1/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
3/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Musculoskeletal and connective tissue disorders
Synostosis
|
4.8%
1/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Nervous system disorders
Syncope
|
0.00%
0/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.92%
1/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
Other adverse events
| Measure |
CKD Patients: Valsartan+Enalapril
n=21 participants at risk
Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Valsartan
n=103 participants at risk
Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
CKD Patients: Enalapril
n=17 participants at risk
Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
Non-CKD Patients: Enalapril
n=109 participants at risk
Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
1.9%
2/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
5.9%
1/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
3.7%
4/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
5.9%
1/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
1.8%
2/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
2/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
2.8%
3/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
General disorders
Pyrexia
|
14.3%
3/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
4.9%
5/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
3.7%
4/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
5.8%
6/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
5.9%
1/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
8.3%
9/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Infections and infestations
Pharyngitis
|
9.5%
2/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
6.8%
7/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
11.8%
2/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
10.1%
11/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.97%
1/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
5.9%
1/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Infections and infestations
Urinary tract infection
|
9.5%
2/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.97%
1/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
5.9%
1/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
1.8%
2/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
19.0%
4/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
11.8%
2/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
2.8%
3/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.97%
1/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
5.9%
1/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.97%
1/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
5.9%
1/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.97%
1/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.92%
1/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
5.9%
1/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Nervous system disorders
Headache
|
19.0%
4/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
10.7%
11/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
5.9%
1/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
14.7%
16/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
1.9%
2/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
11.8%
2/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.92%
1/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
|
Vascular disorders
Hypotension
|
9.5%
2/21 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/103 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/17 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
0.00%
0/109 • Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
|
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