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Trial record 22 of 101 for:    AMLODIPINE AND VALSARTAN

Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00446563
Recruitment Status : Completed
First Posted : March 13, 2007
Results First Posted : April 27, 2011
Last Update Posted : May 11, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension; Hypertrophy, Left Ventricular
Interventions Drug: Valsartan
Drug: Amlodipine
Drug: Hydrochlorothiazide
Drug: Losartan
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 43 47
Completed 36 38
Not Completed 7 9
Reason Not Completed
Adverse Event             4             3
Abnormal laboratory value(s)             0             1
Abnormal test procedure result(s)             1             0
Unsatisfactory therapeutic effect             0             3
Withdrawal by Subject             2             1
Administrative problems             0             1
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 43 47 90
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 47 participants 90 participants
58.2  (12.2) 57.2  (10.9) 57.7  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 47 participants 90 participants
Female
12
  27.9%
13
  27.7%
25
  27.8%
Male
31
  72.1%
34
  72.3%
65
  72.2%
1.Primary Outcome
Title Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)
Hide Description [Not Specified]
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Mean (Standard Deviation)
Unit of Measure: g/m˄2
-7.1  (16.50) -9.1  (18.89)
2.Secondary Outcome
Title Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI
Hide Description [Not Specified]
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Mean (Standard Deviation)
Unit of Measure: g/m˄2
-3.5  (7.4) -4.4  (9.3)
3.Secondary Outcome
Title Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI
Hide Description [Not Specified]
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Mean (Standard Deviation)
Unit of Measure: mm
-1.1  (1.5) -0.6  (1.3)
4.Secondary Outcome
Title Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI
Hide Description [Not Specified]
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Mean (Standard Deviation)
Unit of Measure: mm
-0.4  (1.1) -0.3  (1.2)
5.Secondary Outcome
Title Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI
Hide Description Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Mean (Standard Deviation)
Unit of Measure: Percentage
-0.8  (6.7) -0.4  (5.9)
6.Secondary Outcome
Title Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI
Hide Description [Not Specified]
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Mean (Standard Deviation)
Unit of Measure: ml
0.1  (19.9) -6.4  (22.9)
7.Secondary Outcome
Title Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI
Hide Description [Not Specified]
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Mean (Standard Deviation)
Unit of Measure: ml
0.0  (9.6) -3.0  (11.2)
8.Secondary Outcome
Title Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI
Hide Description [Not Specified]
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Mean (Standard Deviation)
Unit of Measure: ml
0.4  (10.3) -1.5  (10.3)
9.Secondary Outcome
Title Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI
Hide Description [Not Specified]
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Mean (Standard Deviation)
Unit of Measure: ml
0.2  (5.1) -0.8  (5.1)
10.Secondary Outcome
Title Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI
Hide Description [Not Specified]
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Mean (Standard Deviation)
Unit of Measure: cm˄2
-0.6  (3.2) -1.0  (4.5)
11.Secondary Outcome
Title Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI
Hide Description [Not Specified]
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Mean (Standard Deviation)
Unit of Measure: mm
0.1  (1.9) -0.8  (1.6)
12.Secondary Outcome
Title Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)
Hide Description [Not Specified]
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of the sample of all randomized patients who applied study medication at least once.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Mean (Standard Deviation)
Unit of Measure: pg/ml
-4.5  (56.41) -40.1  (74.09)
13.Secondary Outcome
Title Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)
Hide Description [Not Specified]
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of the sample of all randomized patients who applied study medication at least once.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Mean (Standard Deviation)
Unit of Measure: mg/l
0.8  (6.09) -2.1  (9.90)
14.Secondary Outcome
Title Percentage of Participants Achieving Target Blood Pressure at Week 52
Hide Description 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.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Measure Type: Number
Unit of Measure: Percentage of participants
53.5 14.9
15.Secondary Outcome
Title Percentage of Participants Who Experienced Adverse Events (AEs)
Hide Description 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.
Time Frame Baseline to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of the sample of all randomized patients who applied study medication at least once.
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 47
Measure Type: Number
Unit of Measure: Percentage of participants
69.8 68.1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valsartan and Amlodipine Losartan and HCTZ
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Valsartan and Amlodipine Losartan and HCTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Valsartan and Amlodipine Losartan and HCTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   2/43 (4.65%)   6/47 (12.77%) 
Cardiac disorders     
BRADYCARDIA  1  0/43 (0.00%)  1/47 (2.13%) 
CORONARY ARTERY DISEASE  1  1/43 (2.33%)  0/47 (0.00%) 
MYOCARDIAL INFARCTION  1  1/43 (2.33%)  0/47 (0.00%) 
TACHYCARDIA  1  0/43 (0.00%)  1/47 (2.13%) 
Congenital, familial and genetic disorders     
HYDROCELE  1  1/43 (2.33%)  0/47 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  0/43 (0.00%)  1/47 (2.13%) 
ANAL HAEMORRHAGE  1  0/43 (0.00%)  1/47 (2.13%) 
DIARRHOEA  1  0/43 (0.00%)  1/47 (2.13%) 
Hepatobiliary disorders     
CHOLECYSTITIS  1  1/43 (2.33%)  0/47 (0.00%) 
Infections and infestations     
ERYSIPELAS  1  0/43 (0.00%)  1/47 (2.13%) 
VESTIBULAR NEURONITIS  1  0/43 (0.00%)  1/47 (2.13%) 
Metabolism and nutrition disorders     
HYPERTRIGLYCERIDAEMIA  1  0/43 (0.00%)  1/47 (2.13%) 
HYPOKALAEMIA  1  0/43 (0.00%)  1/47 (2.13%) 
Musculoskeletal and connective tissue disorders     
OSTEOARTHRITIS  1  0/43 (0.00%)  1/47 (2.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
COLON CANCER  1  0/43 (0.00%)  1/47 (2.13%) 
METASTATIC NEOPLASM  1  1/43 (2.33%)  0/47 (0.00%) 
Nervous system disorders     
THALAMIC INFARCTION  1  0/43 (0.00%)  1/47 (2.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valsartan and Amlodipine Losartan and HCTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   15/43 (34.88%)   16/47 (34.04%) 
Gastrointestinal disorders     
DIARRHOEA  1  1/43 (2.33%)  4/47 (8.51%) 
NAUSEA  1  1/43 (2.33%)  3/47 (6.38%) 
General disorders     
OEDEMA PERIPHERAL  1  4/43 (9.30%)  0/47 (0.00%) 
Infections and infestations     
BRONCHITIS  1  3/43 (6.98%)  0/47 (0.00%) 
NASOPHARYNGITIS  1  3/43 (6.98%)  7/47 (14.89%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  5/43 (11.63%)  2/47 (4.26%) 
Nervous system disorders     
HEADACHE  1  0/43 (0.00%)  3/47 (6.38%) 
Skin and subcutaneous tissue disorders     
ECZEMA  1  2/43 (4.65%)  3/47 (6.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00446563     History of Changes
Other Study ID Numbers: CVAA489ADE02
First Submitted: March 12, 2007
First Posted: March 13, 2007
Results First Submitted: March 31, 2011
Results First Posted: April 27, 2011
Last Update Posted: May 11, 2011