Trial Outcomes & Findings for Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease (NCT NCT01129557)
NCT ID: NCT01129557
Last Updated: 2014-05-15
Results Overview
The primary outcome of this study is the 9-month cumulative incidence of aldosterone breakthrough, defined as a sustained increase in 24-hour urine aldosterone above baseline, in each treatment arm.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
9 months
Results posted on
2014-05-15
Participant Flow
Participant milestones
| Measure |
Diovan
Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
|
Tekturna
Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
|
Tekturna + Diovan
Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months \& Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
14
|
|
Overall Study
COMPLETED
|
11
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
4
|
Reasons for withdrawal
| Measure |
Diovan
Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
|
Tekturna
Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
|
Tekturna + Diovan
Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months \& Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
2
|
|
Overall Study
Novartis terminated study early
|
3
|
3
|
2
|
Baseline Characteristics
Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease
Baseline characteristics by cohort
| Measure |
Diovan
n=15 Participants
Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
|
Tekturna
n=17 Participants
Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
|
Tekturna+Diovan
n=14 Participants
Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months \& Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 9 monthsThe primary outcome of this study is the 9-month cumulative incidence of aldosterone breakthrough, defined as a sustained increase in 24-hour urine aldosterone above baseline, in each treatment arm.
Outcome measures
| Measure |
Diovan
n=11 Participants
valsartan \[angiotensin receptor blocker (ARB)\] : Diovan 320 mg PO once daily for 9 months
|
Tekturna
n=12 Participants
aliskiren \[direct renin inhibitor (DRI)\] : Tekturna 300 mg PO once daily for 9 months
|
Tekturna + Diovan
n=10 Participants
aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
|
9 Months: Subjects Without Aldosterone Breakthrough
|
Baseline: Subjects With Aldosterone Breakthrough
|
3 Months: Subjects With Aldosterone Breakthrough
|
6 Months: Subjects With Aldosterone Breakthrough
|
9 Months: Subjects With Aldosterone Breakthrough
|
|---|---|---|---|---|---|---|---|---|
|
Cumulative Incidence of Aldosterone Breakthrough in Subjects Who Completed the 9-month Study Protocol.
|
3 participants
|
3 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-monthsMean serum aldosterone at baseline, 3-, 6-, and 9-months.
Outcome measures
| Measure |
Diovan
n=24 Participants
valsartan \[angiotensin receptor blocker (ARB)\] : Diovan 320 mg PO once daily for 9 months
|
Tekturna
n=24 Participants
aliskiren \[direct renin inhibitor (DRI)\] : Tekturna 300 mg PO once daily for 9 months
|
Tekturna + Diovan
n=24 Participants
aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
|
9 Months: Subjects Without Aldosterone Breakthrough
n=24 Participants
|
Baseline: Subjects With Aldosterone Breakthrough
n=9 Participants
|
3 Months: Subjects With Aldosterone Breakthrough
n=9 Participants
|
6 Months: Subjects With Aldosterone Breakthrough
n=9 Participants
|
9 Months: Subjects With Aldosterone Breakthrough
n=9 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Serum Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
|
9.1 ng/dL
Standard Deviation 5.2
|
4.8 ng/dL
Standard Deviation 3.1
|
4.9 ng/dL
Standard Deviation 3.6
|
4.9 ng/dL
Standard Deviation 3.8
|
7.3 ng/dL
Standard Deviation 4.5
|
8.5 ng/dL
Standard Deviation 4.3
|
11.7 ng/dL
Standard Deviation 5.6
|
11.7 ng/dL
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-monthsMean urine aldosterone at baseline, 3-, 6-, and 9-months.
Outcome measures
| Measure |
Diovan
n=24 Participants
valsartan \[angiotensin receptor blocker (ARB)\] : Diovan 320 mg PO once daily for 9 months
|
Tekturna
n=24 Participants
aliskiren \[direct renin inhibitor (DRI)\] : Tekturna 300 mg PO once daily for 9 months
|
Tekturna + Diovan
n=24 Participants
aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
|
9 Months: Subjects Without Aldosterone Breakthrough
n=24 Participants
|
Baseline: Subjects With Aldosterone Breakthrough
n=9 Participants
|
3 Months: Subjects With Aldosterone Breakthrough
n=9 Participants
|
6 Months: Subjects With Aldosterone Breakthrough
n=9 Participants
|
9 Months: Subjects With Aldosterone Breakthrough
n=9 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Urine Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
|
10.9 ug/day
Standard Deviation 9.4
|
4.4 ug/day
Standard Deviation 3.3
|
5.5 ug/day
Standard Deviation 4.3
|
4.3 ug/day
Standard Deviation 2.3
|
7.4 ug/day
Standard Deviation 4.5
|
11.0 ug/day
Standard Deviation 6.2
|
14.4 ug/day
Standard Deviation 8.2
|
12.8 ug/day
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-monthsMean serum potassium at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma \& urine aldosterone measurements.)
Outcome measures
| Measure |
Diovan
n=24 Participants
valsartan \[angiotensin receptor blocker (ARB)\] : Diovan 320 mg PO once daily for 9 months
|
Tekturna
n=24 Participants
aliskiren \[direct renin inhibitor (DRI)\] : Tekturna 300 mg PO once daily for 9 months
|
Tekturna + Diovan
n=24 Participants
aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
|
9 Months: Subjects Without Aldosterone Breakthrough
n=24 Participants
|
Baseline: Subjects With Aldosterone Breakthrough
n=9 Participants
|
3 Months: Subjects With Aldosterone Breakthrough
n=9 Participants
|
6 Months: Subjects With Aldosterone Breakthrough
n=9 Participants
|
9 Months: Subjects With Aldosterone Breakthrough
n=9 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Serum Potassium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
|
4.2 mmol/L
Standard Deviation 0.5
|
4.4 mmol/L
Standard Deviation 0.5
|
4.4 mmol/L
Standard Deviation 0.4
|
4.4 mmol/L
Standard Deviation 0.4
|
4.3 mmol/L
Standard Deviation 0.2
|
4.2 mmol/L
Standard Deviation 0.2
|
4.3 mmol/L
Standard Deviation 0.2
|
4.4 mmol/L
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-monthsMean 24-hour urine sodium (mmol/day) at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma \& urine aldosterone measurements.)
Outcome measures
| Measure |
Diovan
n=24 Participants
valsartan \[angiotensin receptor blocker (ARB)\] : Diovan 320 mg PO once daily for 9 months
|
Tekturna
n=24 Participants
aliskiren \[direct renin inhibitor (DRI)\] : Tekturna 300 mg PO once daily for 9 months
|
Tekturna + Diovan
n=24 Participants
aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
|
9 Months: Subjects Without Aldosterone Breakthrough
n=24 Participants
|
Baseline: Subjects With Aldosterone Breakthrough
n=9 Participants
|
3 Months: Subjects With Aldosterone Breakthrough
n=9 Participants
|
6 Months: Subjects With Aldosterone Breakthrough
n=9 Participants
|
9 Months: Subjects With Aldosterone Breakthrough
n=9 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Mean 24-hour Urine Sodium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
|
158 mmol/day
Standard Deviation 67
|
180 mmol/day
Standard Deviation 81
|
188 mmol/day
Standard Deviation 66
|
169 mmol/day
Standard Deviation 70
|
258 mmol/day
Standard Deviation 98
|
220 mmol/day
Standard Deviation 65
|
250 mmol/day
Standard Deviation 102
|
200 mmol/day
Standard Deviation 54
|
SECONDARY outcome
Timeframe: Baseline and Final (9 month)Compares baseline and final (9 month) blood pressure for subjects with and without aldosterone breakthrough
Outcome measures
| Measure |
Diovan
n=24 Participants
valsartan \[angiotensin receptor blocker (ARB)\] : Diovan 320 mg PO once daily for 9 months
|
Tekturna
n=24 Participants
aliskiren \[direct renin inhibitor (DRI)\] : Tekturna 300 mg PO once daily for 9 months
|
Tekturna + Diovan
n=9 Participants
aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
|
9 Months: Subjects Without Aldosterone Breakthrough
n=9 Participants
|
Baseline: Subjects With Aldosterone Breakthrough
|
3 Months: Subjects With Aldosterone Breakthrough
|
6 Months: Subjects With Aldosterone Breakthrough
|
9 Months: Subjects With Aldosterone Breakthrough
|
|---|---|---|---|---|---|---|---|---|
|
Pre- and Post-treatment Blood Pressure in Subjects With and Without Aldosterone Breakthrough.
Office systolic Blood Pressure
|
134.0 mm Hg
Standard Deviation 10.9
|
122.0 mm Hg
Standard Deviation 12.0
|
136.3 mm Hg
Standard Deviation 9.8
|
127.9 mm Hg
Standard Deviation 10.8
|
—
|
—
|
—
|
—
|
|
Pre- and Post-treatment Blood Pressure in Subjects With and Without Aldosterone Breakthrough.
Office diastolic Blood Pressure
|
83.7 mm Hg
Standard Deviation 8.9
|
74.0 mm Hg
Standard Deviation 9.3
|
87.7 mm Hg
Standard Deviation 6.6
|
81.6 mm Hg
Standard Deviation 10.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Final (9 month)Compares baseline and final (9 month) serum creatinine for subjects with and without aldosterone breakthrough
Outcome measures
| Measure |
Diovan
n=24 Participants
valsartan \[angiotensin receptor blocker (ARB)\] : Diovan 320 mg PO once daily for 9 months
|
Tekturna
n=24 Participants
aliskiren \[direct renin inhibitor (DRI)\] : Tekturna 300 mg PO once daily for 9 months
|
Tekturna + Diovan
n=9 Participants
aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
|
9 Months: Subjects Without Aldosterone Breakthrough
n=9 Participants
|
Baseline: Subjects With Aldosterone Breakthrough
|
3 Months: Subjects With Aldosterone Breakthrough
|
6 Months: Subjects With Aldosterone Breakthrough
|
9 Months: Subjects With Aldosterone Breakthrough
|
|---|---|---|---|---|---|---|---|---|
|
Pre- and Post-treatment Serum Creatinine in Subjects With and Without Aldosterone Breakthrough.
|
1.2 mg/dL
Standard Deviation 0.3
|
1.3 mg/dL
Standard Deviation 0.4
|
1.2 mg/dL
Standard Deviation 0.5
|
1.4 mg/dL
Standard Deviation 1.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Final (9 month)Compares baseline and final (9 month) serum potassium for subjects with and without aldosterone breakthrough
Outcome measures
| Measure |
Diovan
n=24 Participants
valsartan \[angiotensin receptor blocker (ARB)\] : Diovan 320 mg PO once daily for 9 months
|
Tekturna
n=24 Participants
aliskiren \[direct renin inhibitor (DRI)\] : Tekturna 300 mg PO once daily for 9 months
|
Tekturna + Diovan
n=9 Participants
aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
|
9 Months: Subjects Without Aldosterone Breakthrough
n=9 Participants
|
Baseline: Subjects With Aldosterone Breakthrough
|
3 Months: Subjects With Aldosterone Breakthrough
|
6 Months: Subjects With Aldosterone Breakthrough
|
9 Months: Subjects With Aldosterone Breakthrough
|
|---|---|---|---|---|---|---|---|---|
|
Pre- and Post-treatment Serum Potassium in Subjects With and Without Aldosterone Breakthrough.
|
4.2 (mmol/L)
Standard Deviation 0.5
|
4.4 (mmol/L)
Standard Deviation 0.4
|
4.3 (mmol/L)
Standard Deviation 0.2
|
4.4 (mmol/L)
Standard Deviation 0.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Final (9 month)Compares baseline and final (9 month) 24-hour urine protein for subjects with and without aldosterone breakthrough
Outcome measures
| Measure |
Diovan
n=24 Participants
valsartan \[angiotensin receptor blocker (ARB)\] : Diovan 320 mg PO once daily for 9 months
|
Tekturna
n=24 Participants
aliskiren \[direct renin inhibitor (DRI)\] : Tekturna 300 mg PO once daily for 9 months
|
Tekturna + Diovan
n=9 Participants
aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
|
9 Months: Subjects Without Aldosterone Breakthrough
n=9 Participants
|
Baseline: Subjects With Aldosterone Breakthrough
|
3 Months: Subjects With Aldosterone Breakthrough
|
6 Months: Subjects With Aldosterone Breakthrough
|
9 Months: Subjects With Aldosterone Breakthrough
|
|---|---|---|---|---|---|---|---|---|
|
Pre- and Post-treatment 24-hour Urine Protein in Subjects With and Without Aldosterone Breakthrough.
|
2827 (mg/day)
Standard Deviation 2736
|
1911 (mg/day)
Standard Deviation 2958
|
3844 (mg/day)
Standard Deviation 3502
|
2681 (mg/day)
Standard Deviation 2967
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Final (9 month)Compares baseline and final (9 month) 24-hour urine sodium for subjects with and without aldosterone breakthrough
Outcome measures
| Measure |
Diovan
n=24 Participants
valsartan \[angiotensin receptor blocker (ARB)\] : Diovan 320 mg PO once daily for 9 months
|
Tekturna
n=24 Participants
aliskiren \[direct renin inhibitor (DRI)\] : Tekturna 300 mg PO once daily for 9 months
|
Tekturna + Diovan
n=9 Participants
aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
|
9 Months: Subjects Without Aldosterone Breakthrough
n=9 Participants
|
Baseline: Subjects With Aldosterone Breakthrough
|
3 Months: Subjects With Aldosterone Breakthrough
|
6 Months: Subjects With Aldosterone Breakthrough
|
9 Months: Subjects With Aldosterone Breakthrough
|
|---|---|---|---|---|---|---|---|---|
|
Pre- and Post-treatment 24-hour Urine Sodium in Subjects With and Without Aldosterone Breakthrough.
|
158 (mmol/day)
Standard Deviation 67
|
169 (mmol/day)
Standard Deviation 70
|
258 (mmol/day)
Standard Deviation 98
|
200 (mmol/day)
Standard Deviation 54
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Final (9 month)Compares baseline and final (9 month) 24-hour urine aldosterone for subjects with and without aldosterone breakthrough
Outcome measures
| Measure |
Diovan
n=24 Participants
valsartan \[angiotensin receptor blocker (ARB)\] : Diovan 320 mg PO once daily for 9 months
|
Tekturna
n=24 Participants
aliskiren \[direct renin inhibitor (DRI)\] : Tekturna 300 mg PO once daily for 9 months
|
Tekturna + Diovan
n=9 Participants
aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
|
9 Months: Subjects Without Aldosterone Breakthrough
n=9 Participants
|
Baseline: Subjects With Aldosterone Breakthrough
|
3 Months: Subjects With Aldosterone Breakthrough
|
6 Months: Subjects With Aldosterone Breakthrough
|
9 Months: Subjects With Aldosterone Breakthrough
|
|---|---|---|---|---|---|---|---|---|
|
Pre- and Post-treatment 24-urine Aldosterone in Subjects With and Without Aldosterone Breakthrough.
|
10.9 (ug/day)
Standard Deviation 9.4
|
4.3 (ug/day)
Standard Deviation 2.3
|
7.4 (ug/day)
Standard Deviation 4.5
|
12.8 (ug/day)
Standard Deviation 5.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Final (9 month)Compares baseline and final (9 month) serum aldosterone for subjects with and without aldosterone breakthrough
Outcome measures
| Measure |
Diovan
n=24 Participants
valsartan \[angiotensin receptor blocker (ARB)\] : Diovan 320 mg PO once daily for 9 months
|
Tekturna
n=24 Participants
aliskiren \[direct renin inhibitor (DRI)\] : Tekturna 300 mg PO once daily for 9 months
|
Tekturna + Diovan
n=9 Participants
aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
|
9 Months: Subjects Without Aldosterone Breakthrough
n=9 Participants
|
Baseline: Subjects With Aldosterone Breakthrough
|
3 Months: Subjects With Aldosterone Breakthrough
|
6 Months: Subjects With Aldosterone Breakthrough
|
9 Months: Subjects With Aldosterone Breakthrough
|
|---|---|---|---|---|---|---|---|---|
|
Pre- and Post-treatment Serum Aldosterone in Subjects With and Without Aldosterone Breakthrough.
|
9.1 (ng/dL)
Standard Deviation 5.2
|
4.9 (ng/dL)
Standard Deviation 3.8
|
7.3 (ng/dL)
Standard Deviation 4.6
|
11.7 (ng/dL)
Standard Deviation 7.5
|
—
|
—
|
—
|
—
|
Adverse Events
Tekturna
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Diovan
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Tekturna + Diovan
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tekturna
n=17 participants at risk
Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
|
Diovan
n=15 participants at risk
Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
|
Tekturna + Diovan
n=14 participants at risk
Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months \& Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
|
|---|---|---|---|
|
Renal and urinary disorders
>25% increase in creatinine
|
0.00%
0/17
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
|
General disorders
Hypotension
|
5.9%
1/17 • Number of events 1
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1
|
0.00%
0/15
|
0.00%
0/14
|
Additional Information
Andrew Bomback, MD
Columbia University Medical Center, Division of Nephrology
Phone: 212-305-5020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place