Trial Outcomes & Findings for Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy (NCT NCT00446563)
NCT ID: NCT00446563
Last Updated: 2011-05-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
90 participants
Primary outcome timeframe
Baseline to week 52
Results posted on
2011-05-11
Participant Flow
Participant milestones
| Measure |
Valsartan and Amlodipine
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
47
|
|
Overall Study
COMPLETED
|
36
|
38
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
| Measure |
Valsartan and Amlodipine
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Abnormal laboratory value(s)
|
0
|
1
|
|
Overall Study
Abnormal test procedure result(s)
|
1
|
0
|
|
Overall Study
Unsatisfactory therapeutic effect
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Administrative problems
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy
Baseline characteristics by cohort
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.2 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 52Population: The intention-to-treat (ITT) population consisted of all patients who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)
|
-7.1 g/m˄2
Standard Deviation 16.50
|
-9.1 g/m˄2
Standard Deviation 18.89
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI
|
-3.5 g/m˄2
Standard Deviation 7.4
|
-4.4 g/m˄2
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI
|
-1.1 mm
Standard Deviation 1.5
|
-0.6 mm
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI
|
-0.4 mm
Standard Deviation 1.1
|
-0.3 mm
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.
Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI
|
-0.8 Percentage
Standard Deviation 6.7
|
-0.4 Percentage
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI
|
0.1 ml
Standard Deviation 19.9
|
-6.4 ml
Standard Deviation 22.9
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI
|
0.0 ml
Standard Deviation 9.6
|
-3.0 ml
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI
|
0.4 ml
Standard Deviation 10.3
|
-1.5 ml
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI
|
0.2 ml
Standard Deviation 5.1
|
-0.8 ml
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI
|
-0.6 cm˄2
Standard Deviation 3.2
|
-1.0 cm˄2
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI
|
0.1 mm
Standard Deviation 1.9
|
-0.8 mm
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: The safety population consisted of the sample of all randomized patients who applied study medication at least once.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)
|
-4.5 pg/ml
Standard Deviation 56.41
|
-40.1 pg/ml
Standard Deviation 74.09
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: The safety population consisted of the sample of all randomized patients who applied study medication at least once.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)
|
0.8 mg/l
Standard Deviation 6.09
|
-2.1 mg/l
Standard Deviation 9.90
|
SECONDARY outcome
Timeframe: Week 52Population: The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.
Target blood pressure defined as having a mean sitting systolic blood pressure (MSSBP) \< 140 mm Hg and a mean sitting diastolic blood pressure (MSDBP) \< 90 mm Hg.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Percentage of Participants Achieving Target Blood Pressure at Week 52
|
53.5 Percentage of participants
|
14.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to week 52Population: The safety population consisted of the sample of all randomized patients who applied study medication at least once.
An adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after obtaining informed consent even if the event was not considered to be related to study drug. Medical conditions/diseases present before obtaining informed consent were only considered adverse events if they worsened after study start. Abnormal laboratory values or test results constituted adverse events only if they induced clinical signs or symptoms, required study drug discontinuation or required therapy.
Outcome measures
| Measure |
Valsartan and Amlodipine
n=43 Participants
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 Participants
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Percentage of Participants Who Experienced Adverse Events (AEs)
|
69.8 Percentage of participants
|
68.1 Percentage of participants
|
Adverse Events
Valsartan and Amlodipine
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Losartan and HCTZ
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valsartan and Amlodipine
n=43 participants at risk
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 participants at risk
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/43
|
2.1%
1/47
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
2.3%
1/43
|
0.00%
0/47
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
2.3%
1/43
|
0.00%
0/47
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/43
|
2.1%
1/47
|
|
Congenital, familial and genetic disorders
HYDROCELE
|
2.3%
1/43
|
0.00%
0/47
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/43
|
2.1%
1/47
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.00%
0/43
|
2.1%
1/47
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/43
|
2.1%
1/47
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
2.3%
1/43
|
0.00%
0/47
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/43
|
2.1%
1/47
|
|
Infections and infestations
VESTIBULAR NEURONITIS
|
0.00%
0/43
|
2.1%
1/47
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/43
|
2.1%
1/47
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/43
|
2.1%
1/47
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/43
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/43
|
2.1%
1/47
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
2.3%
1/43
|
0.00%
0/47
|
|
Nervous system disorders
THALAMIC INFARCTION
|
0.00%
0/43
|
2.1%
1/47
|
Other adverse events
| Measure |
Valsartan and Amlodipine
n=43 participants at risk
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
Losartan and HCTZ
n=47 participants at risk
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
|
|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
2.3%
1/43
|
8.5%
4/47
|
|
Gastrointestinal disorders
NAUSEA
|
2.3%
1/43
|
6.4%
3/47
|
|
General disorders
OEDEMA PERIPHERAL
|
9.3%
4/43
|
0.00%
0/47
|
|
Infections and infestations
BRONCHITIS
|
7.0%
3/43
|
0.00%
0/47
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.0%
3/43
|
14.9%
7/47
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.6%
5/43
|
4.3%
2/47
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/43
|
6.4%
3/47
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
4.7%
2/43
|
6.4%
3/47
|
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