Trial Outcomes & Findings for A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide. (NCT NCT00386607)
NCT ID: NCT00386607
Last Updated: 2014-02-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
601 participants
Primary outcome timeframe
Month 12
Results posted on
2014-02-10
Participant Flow
Participant milestones
| Measure |
Core Treatment
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
|
Extension Treatment
For patients entering into extension, those previously treated with HCTZ (12.5 or 25 mg) in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension.
Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.
The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the msSBP was ≥140 mmHg and/or the msDBP was ≥90 mmHg for 2 consecutive visits.
|
|---|---|---|
|
Core
STARTED
|
601
|
0
|
|
Core
COMPLETED
|
486
|
0
|
|
Core
NOT COMPLETED
|
115
|
0
|
|
Extension
STARTED
|
0
|
162
|
|
Extension
COMPLETED
|
0
|
145
|
|
Extension
NOT COMPLETED
|
0
|
17
|
Reasons for withdrawal
| Measure |
Core Treatment
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
|
Extension Treatment
For patients entering into extension, those previously treated with HCTZ (12.5 or 25 mg) in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension.
Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.
The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the msSBP was ≥140 mmHg and/or the msDBP was ≥90 mmHg for 2 consecutive visits.
|
|---|---|---|
|
Core
Adverse Event
|
40
|
0
|
|
Core
Abnormal laboratory value(s)
|
3
|
0
|
|
Core
Unsatisfactory therapeutic effect
|
23
|
0
|
|
Core
Condition no longer requires study drug
|
4
|
0
|
|
Core
Patient withdrew consent
|
15
|
0
|
|
Core
Lost to Follow-up
|
23
|
0
|
|
Core
Administrative problems
|
1
|
0
|
|
Core
Protocol Deviation
|
6
|
0
|
|
Extension
Adverse Event
|
0
|
6
|
|
Extension
Abnormal laboratory value(s)
|
0
|
1
|
|
Extension
Administrative problems
|
0
|
1
|
|
Extension
Lost to Follow-up
|
0
|
3
|
|
Extension
Patient withdrew consent
|
0
|
5
|
|
Extension
Unsatisfactory therapeutic effect
|
0
|
1
|
Baseline Characteristics
A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.
Baseline characteristics by cohort
| Measure |
Core Treatment
n=601 Participants
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
|
|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 11.20 • n=99 Participants
|
|
Sex: Female, Male
Female
|
271 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
330 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: Treated population: All patients who received at least one dose of Aliskiren/Valsartan
Outcome measures
| Measure |
Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ
n=601 Participants
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
|
|---|---|
|
Overall Percentage of Patients With Adverse Events
|
76.2 percentage of patients
|
PRIMARY outcome
Timeframe: Month 18adverse event data obtained from both the core study and the 6 month extension study.
Outcome measures
| Measure |
Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ
n=310 Participants
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
|
|---|---|
|
Overall Percentage of Patients With Adverse Events
|
61.6 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54Population: Treated population
Outcome measures
| Measure |
Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ
n=601 Participants
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
|
|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Week 2 (Visit 5)
|
-7.9 mmHg
Standard Deviation 7.14
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Week 4 (Visit 6)
|
-10.8 mmHg
Standard Deviation 7.83
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Week 6 (Visit 7)
|
-11.8 mmHg
Standard Deviation 8.09
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Week 10 (Visit 8)
|
-12.5 mmHg
Standard Deviation 8.26
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Week 14 (Visit 9)
|
-13.7 mmHg
Standard Deviation 7.87
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Week 18 (Visit 10)
|
-15.0 mmHg
Standard Deviation 8.00
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Week 28 (Visit 11)
|
-15.2 mmHg
Standard Deviation 7.24
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Week 41 (Visit 12)
|
-15.2 mmHg
Standard Deviation 7.60
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Week 54 (Visit 13)
|
-14.2 mmHg
Standard Deviation 7.96
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Endpoint (value at week 54 or LOCF)
|
-13.4 mmHg
Standard Deviation 8.75
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54Population: Treated population
Outcome measures
| Measure |
Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ
n=601 Participants
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
|
|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Week 2 (Visit 5)
|
-11.0 mmHg
Standard Deviation 12.42
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Week 4 (Visit 6)
|
-15.0 mmHg
Standard Deviation 14.03
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Week 6 (Visit 7)
|
-17.6 mmHg
Standard Deviation 14.10
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Week 10 (Visit 8)
|
-18.4 mmHg
Standard Deviation 14.37
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Week 14 (Visit 9)
|
-20.7 mmHg
Standard Deviation 13.42
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Week 18 (Visit 10)
|
-22.6 mmHg
Standard Deviation 14.01
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Week 28 (Visit 11)
|
-24.3 mmHg
Standard Deviation 13.70
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Week 41 (Visit 12)
|
-24.3 mmHg
Standard Deviation 13.27
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Week 54 (Visit 13)
|
-22.3 mmHg
Standard Deviation 14.51
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Endpoint (value at week 54 or LOCF)
|
-20.5 mmHg
Standard Deviation 16.40
|
SECONDARY outcome
Timeframe: .Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54Population: Treated population
Outcome measures
| Measure |
Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ
n=601 Participants
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
|
|---|---|
|
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Week 14 (Visit 9)
|
68.7 Percentage of patients
|
|
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Week 18 (Visit 10)
|
76.4 Percentage of patients
|
|
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Week 28 (Visit 11)
|
77.9 Percentage of patients
|
|
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Week 41 (Visit 12)
|
78.2 Percentage of patients
|
|
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Week 54 (Visit 13)
|
71.7 Percentage of patients
|
|
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Endpoint (value at week 54 or LOCF)
|
66.9 Percentage of patients
|
|
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Week 2 (Visit 5)
|
32.8 Percentage of patients
|
|
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Week 4 (Visit 6)
|
45.9 Percentage of patients
|
|
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Week 6 (Visit 7)
|
52.4 Percentage of patients
|
|
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Week 10 (Visit 8)
|
60.8 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and Month 18Population: Treated population
Outcome measures
| Measure |
Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ
n=179 Participants
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
|
|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure
|
-18.3 mmHg
Standard Deviation 8.52
|
SECONDARY outcome
Timeframe: Baseline and Month 18Population: Treated population
Outcome measures
| Measure |
Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ
n=179 Participants
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
|
|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure
|
-28.8 mmHg
Standard Deviation 14.80
|
SECONDARY outcome
Timeframe: Month 18Population: Treated population
Outcome measures
| Measure |
Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ
n=179 Participants
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
|
|---|---|
|
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment
|
86.6 Percentage of patients
|
Adverse Events
Core Period: Aliskiren 150 mg / Valsartan 160 mg Alone
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Core Period: Aliskiren 300 mg / Valsartan 320 mg Alone
Serious events: 14 serious events
Other events: 185 other events
Deaths: 0 deaths
Core Period: Aliskiren / Valsartan
Serious events: 17 serious events
Other events: 215 other events
Deaths: 0 deaths
Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg
Serious events: 3 serious events
Other events: 47 other events
Deaths: 0 deaths
Core and Extension: Aliskiren / Valsartan / HCTZ 25 mg
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
Core and Extension: Total
Serious events: 26 serious events
Other events: 251 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Core Period: Aliskiren 150 mg / Valsartan 160 mg Alone
n=601 participants at risk
Core Period: Aliskiren 150 mg /Valsartan 160 mg alone
|
Core Period: Aliskiren 300 mg / Valsartan 320 mg Alone
n=585 participants at risk
Core Period: Aliskiren 300 mg /Valsartan 320 mg alone
|
Core Period: Aliskiren / Valsartan
n=601 participants at risk
Core Period: Aliskiren/Valsartan
|
Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg
n=306 participants at risk
Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg
|
Core and Extension: Aliskiren / Valsartan / HCTZ 25 mg
n=137 participants at risk
Core and Extension: Aliskiren/Valsartan/HCTZ 25 mg
|
Core and Extension: Total
n=601 participants at risk
Core and Extension: Total includes all study patients, treated with Aliskiren/Valsartan or Aliskiren//valsartan/HCTZ during core or extension.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Cardiac disorders
Angina pectoris
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.33%
1/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.33%
2/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Eye disorders
Retinal vascular thrombosis
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
General disorders
Generalised oedema
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
General disorders
Pain
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.73%
1/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.73%
1/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.73%
1/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.73%
1/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.73%
1/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.73%
1/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.73%
1/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.73%
1/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.73%
1/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.73%
1/137 • 18 months
All patients who received at least one dose of study medication.
|
0.33%
2/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.33%
1/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.73%
1/137 • 18 months
All patients who received at least one dose of study medication.
|
0.33%
2/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.33%
1/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/585 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.73%
1/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.00%
0/601 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/585 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/306 • 18 months
All patients who received at least one dose of study medication.
|
0.00%
0/137 • 18 months
All patients who received at least one dose of study medication.
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
Other adverse events
| Measure |
Core Period: Aliskiren 150 mg / Valsartan 160 mg Alone
n=601 participants at risk
Core Period: Aliskiren 150 mg /Valsartan 160 mg alone
|
Core Period: Aliskiren 300 mg / Valsartan 320 mg Alone
n=585 participants at risk
Core Period: Aliskiren 300 mg /Valsartan 320 mg alone
|
Core Period: Aliskiren / Valsartan
n=601 participants at risk
Core Period: Aliskiren/Valsartan
|
Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg
n=306 participants at risk
Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg
|
Core and Extension: Aliskiren / Valsartan / HCTZ 25 mg
n=137 participants at risk
Core and Extension: Aliskiren/Valsartan/HCTZ 25 mg
|
Core and Extension: Total
n=601 participants at risk
Core and Extension: Total includes all study patients, treated with Aliskiren/Valsartan or Aliskiren//valsartan/HCTZ during core or extension.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
8/601 • 18 months
All patients who received at least one dose of study medication.
|
4.6%
27/585 • 18 months
All patients who received at least one dose of study medication.
|
5.7%
34/601 • 18 months
All patients who received at least one dose of study medication.
|
2.9%
9/306 • 18 months
All patients who received at least one dose of study medication.
|
0.73%
1/137 • 18 months
All patients who received at least one dose of study medication.
|
7.0%
42/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.50%
3/601 • 18 months
All patients who received at least one dose of study medication.
|
4.1%
24/585 • 18 months
All patients who received at least one dose of study medication.
|
4.5%
27/601 • 18 months
All patients who received at least one dose of study medication.
|
2.0%
6/306 • 18 months
All patients who received at least one dose of study medication.
|
2.2%
3/137 • 18 months
All patients who received at least one dose of study medication.
|
5.7%
34/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
1.00%
6/601 • 18 months
All patients who received at least one dose of study medication.
|
6.7%
39/585 • 18 months
All patients who received at least one dose of study medication.
|
7.2%
43/601 • 18 months
All patients who received at least one dose of study medication.
|
3.3%
10/306 • 18 months
All patients who received at least one dose of study medication.
|
4.4%
6/137 • 18 months
All patients who received at least one dose of study medication.
|
9.0%
54/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.33%
2/601 • 18 months
All patients who received at least one dose of study medication.
|
4.3%
25/585 • 18 months
All patients who received at least one dose of study medication.
|
4.7%
28/601 • 18 months
All patients who received at least one dose of study medication.
|
2.9%
9/306 • 18 months
All patients who received at least one dose of study medication.
|
1.5%
2/137 • 18 months
All patients who received at least one dose of study medication.
|
6.3%
38/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.67%
4/601 • 18 months
All patients who received at least one dose of study medication.
|
3.2%
19/585 • 18 months
All patients who received at least one dose of study medication.
|
3.5%
21/601 • 18 months
All patients who received at least one dose of study medication.
|
1.6%
5/306 • 18 months
All patients who received at least one dose of study medication.
|
4.4%
6/137 • 18 months
All patients who received at least one dose of study medication.
|
5.3%
32/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
2.5%
15/601 • 18 months
All patients who received at least one dose of study medication.
|
6.7%
39/585 • 18 months
All patients who received at least one dose of study medication.
|
8.2%
49/601 • 18 months
All patients who received at least one dose of study medication.
|
2.0%
6/306 • 18 months
All patients who received at least one dose of study medication.
|
5.1%
7/137 • 18 months
All patients who received at least one dose of study medication.
|
10.1%
61/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
2.7%
16/601 • 18 months
All patients who received at least one dose of study medication.
|
5.6%
33/585 • 18 months
All patients who received at least one dose of study medication.
|
7.5%
45/601 • 18 months
All patients who received at least one dose of study medication.
|
1.3%
4/306 • 18 months
All patients who received at least one dose of study medication.
|
1.5%
2/137 • 18 months
All patients who received at least one dose of study medication.
|
8.3%
50/601 • 18 months
All patients who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.17%
1/601 • 18 months
All patients who received at least one dose of study medication.
|
3.9%
23/585 • 18 months
All patients who received at least one dose of study medication.
|
4.0%
24/601 • 18 months
All patients who received at least one dose of study medication.
|
1.6%
5/306 • 18 months
All patients who received at least one dose of study medication.
|
3.6%
5/137 • 18 months
All patients who received at least one dose of study medication.
|
5.2%
31/601 • 18 months
All patients who received at least one dose of study medication.
|
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