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Trial record 39 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age

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: NCT01365481
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : April 21, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypertension
Chronic Kidney Disease
Interventions Drug: Valsartan
Drug: amlodipine
Drug: Hydrochlorothiazide
Enrollment 150
Recruitment Details A 1 arm study of valsartan but with 2 groups for analyses. The valsartan +antihypertensive group includes the patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
Pre-assignment Details These 2 groups were not randomized and considered to be 2 different populations since the patients in the valsartan+antihypertensive group had concomitant antihypertensive usage per individual patient's conditions at any time during treatment period.
Arm/Group Title CKD Patients: Valsartan + Antihypertensive Group CKD Patients: Valsartan Alone Non-CKD Patients: Valsartan + Antihypertensive Group Non-CKD Patients: Valsartan Alone
Hide Arm/Group Description CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study. CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg. Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study. Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
Period Title: Overall Study
Started 23 52 18 57
Completed 16 37 14 50
Not Completed 7 15 4 7
Reason Not Completed
Adverse Event             6             9             0             2
Withdrawal by Subject             0             2             1             1
Lost to Follow-up             1             1             2             3
Abnormal laboratory value(s)             0             1             0             0
Administrative problems             0             1             0             0
Protocol deviation             0             1             0             1
Unsatisfactory therapeutic effect             0             0             1             0
Arm/Group Title CKD Patients: Valsartan + Antihypertensive Group CKD Patients: Valsartan Alone Non-CKD Patients: Valsartan + Antihypertensive Group Non-CKD Patients: Valsartan Alone Total
Hide Arm/Group Description CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study. CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg. Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study. Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg. Total of all reporting groups
Overall Number of Baseline Participants 23 52 18 57 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 52 participants 18 participants 57 participants 150 participants
12.90  (3.35) 12.30  (3.20) 13.79  (2.64) 14.37  (2.83) 13.36  (3.130)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 52 participants 18 participants 57 participants 150 participants
6 – 11 years 10 22 3 10 45
12 – 17 years 13 30 15 47 105
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 52 participants 18 participants 57 participants 150 participants
Female
12
  52.2%
16
  30.8%
3
  16.7%
20
  35.1%
51
  34.0%
Male
11
  47.8%
36
  69.2%
15
  83.3%
37
  64.9%
99
  66.0%
1.Primary Outcome
Title Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
Hide Description Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Time Frame Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set (FAS) included all patients who entered the treatment period. ) This OM looked at the Valsartan + Antihypertensive and Valsartan alone for ALL patients and did not break up the analysis between CKD and non-CKD patients.
Arm/Group Title Valsartan + Antihypertensive Group Valsartan Alone
Hide Arm/Group Description:
Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
Overall Number of Participants Analyzed 41 109
Mean (Standard Deviation)
Unit of Measure: millimeter(s) of mercury (mmHg)
-13.3  (13.69) -15.5  (13.35)
2.Primary Outcome
Title Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
Hide Description Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
Time Frame Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set (FAS) included all patients who entered the treatment period. ) This OM looked at the Valsartan + Antihypertensive and Valsartan alone for ALL patients and did not break up the analysis between CKD and non-CKD patients.
Arm/Group Title Valsartan + Antihypertensive Group Valsartan Alone
Hide Arm/Group Description:
Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
Overall Number of Participants Analyzed 41 109
Mean (Standard Deviation)
Unit of Measure: millimeter(s) of mercury (mmHg)
-10.3  (11.94) -10.8  (11.45)
3.Secondary Outcome
Title Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height
Hide Description Number of Participants with Mean sitting systolic (MSSBP) and mean sitting diastolic(MSDBP) blood pressure and both combined less than the 95th percentile for age, gender and height
Time Frame End Point (Week 78 or Last observation carried forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set (FAS) included all patients who entered the treatment period. This analysis includes only participants with baseline MSSBP or MSDBP or (MSSBP or MSDBP combined) ≥95th percentile for gender, age and height. n analyzed is displayed in left column. This OM did not break up the analysis between CKD and non-CKD patients.
Arm/Group Title Valsartan + Antihypertensive Group Valsartan Alone
Hide Arm/Group Description:
Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
Overall Number of Participants Analyzed 41 109
Measure Type: Number
Unit of Measure: Number of Participants
MSSBP (n=39, 105) 23 90
MSDBP (n=28, 51) 20 47
MSSBP and MSDBP combined (n=40, 105) 22 88
4.Secondary Outcome
Title Percentage of Chronic Kidney Disease (CKD) Patients Who Had >=50% Reduction in Urine Albumin/Creatinine Ratio (UACR) From Baseline to End Point
Hide Description Percentage of Patients with CKD who had Urine albumin creatinine reduction >/= 50% from baseline
Time Frame Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety set (SAF) included all patients who received at least one dose of study medication that has Chronic Kidney Disease (CKD) only
Arm/Group Title Valsartan + Antihypertensive Group Valsartan Alone
Hide Arm/Group Description:
Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
Overall Number of Participants Analyzed 23 52
Measure Type: Number
Unit of Measure: Percentage of patients
50.0 41.9
5.Secondary Outcome
Title Percentage of Chronic Kidney Disease (CKD) Patients Who Had Estimated Glomerular Filtration Rate (eGFR) Decrease > 25 % From Baselinefrom Baseline to End Point
Hide Description Percentage of Patients with CKD who had eGFR decrease > 25 % from Baseline
Time Frame Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety set (SAF) included all patients who received at least one dose of study medication.that has Chronic Kidney Disease (CKD)
Arm/Group Title Valsartan + Antihypertensive Group Valsartan Alone
Hide Arm/Group Description:
Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
Overall Number of Participants Analyzed 23 52
Measure Type: Number
Unit of Measure: Percentage of patients
30.4 27.5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valsartan + Antihypertensive Group Valsartan Alone CKD Patients: Valsartan + Antihypertensive Group CKD Patients: Valsartan Alone Non-CKD Patients: Valsartan + Antihypertensive Group Non-CKD Patients: Valsartan Alone
Hide Arm/Group Description Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study. Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg. CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study. CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg. Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study. Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
All-Cause Mortality
Valsartan + Antihypertensive Group Valsartan Alone CKD Patients: Valsartan + Antihypertensive Group CKD Patients: Valsartan Alone Non-CKD Patients: Valsartan + Antihypertensive Group Non-CKD Patients: Valsartan Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Valsartan + Antihypertensive Group Valsartan Alone CKD Patients: Valsartan + Antihypertensive Group CKD Patients: Valsartan Alone Non-CKD Patients: Valsartan + Antihypertensive Group Non-CKD Patients: Valsartan Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/41 (19.51%)   7/109 (6.42%)   7/23 (30.43%)   4/52 (7.69%)   1/18 (5.56%)   3/57 (5.26%) 
Blood and lymphatic system disorders             
Febrile neutropenia  1  1/41 (2.44%)  0/109 (0.00%)  1/23 (4.35%)  0/52 (0.00%)  0/18 (0.00%)  0/57 (0.00%) 
Gastrointestinal disorders             
Oesophageal polyp  1  1/41 (2.44%)  0/109 (0.00%)  1/23 (4.35%)  0/52 (0.00%)  0/18 (0.00%)  0/57 (0.00%) 
General disorders             
Face oedema  1  1/41 (2.44%)  0/109 (0.00%)  1/23 (4.35%)  0/52 (0.00%)  0/18 (0.00%)  0/57 (0.00%) 
Oedema peripheral  1  1/41 (2.44%)  0/109 (0.00%)  1/23 (4.35%)  0/52 (0.00%)  0/18 (0.00%)  0/57 (0.00%) 
Hepatobiliary disorders             
Cholelithiasis  1  0/41 (0.00%)  1/109 (0.92%)  0/23 (0.00%)  0/52 (0.00%)  0/18 (0.00%)  1/57 (1.75%) 
Infections and infestations             
Gastroenteritis  1  1/41 (2.44%)  0/109 (0.00%)  1/23 (4.35%)  0/52 (0.00%)  0/18 (0.00%)  0/57 (0.00%) 
Pneumonia  1  1/41 (2.44%)  1/109 (0.92%)  1/23 (4.35%)  1/52 (1.92%)  0/18 (0.00%)  0/57 (0.00%) 
Urinary tract infection  1  0/41 (0.00%)  1/109 (0.92%)  0/23 (0.00%)  1/52 (1.92%)  0/18 (0.00%)  0/57 (0.00%) 
Viral upper respiratory tract infection  1  0/41 (0.00%)  1/109 (0.92%)  0/23 (0.00%)  0/52 (0.00%)  0/18 (0.00%)  1/57 (1.75%) 
Investigations             
Glomerular filtration rate decreased  1  1/41 (2.44%)  0/109 (0.00%)  1/23 (4.35%)  0/52 (0.00%)  0/18 (0.00%)  0/57 (0.00%) 
Musculoskeletal and connective tissue disorders             
Synovitis  1  1/41 (2.44%)  0/109 (0.00%)  1/23 (4.35%)  0/52 (0.00%)  0/18 (0.00%)  0/57 (0.00%) 
Nervous system disorders             
Somnolence  1  0/41 (0.00%)  1/109 (0.92%)  0/23 (0.00%)  0/52 (0.00%)  0/18 (0.00%)  1/57 (1.75%) 
Psychiatric disorders             
Drug abuse  1  0/41 (0.00%)  1/109 (0.92%)  0/23 (0.00%)  0/52 (0.00%)  0/18 (0.00%)  1/57 (1.75%) 
Renal and urinary disorders             
Chronic kidney disease  1  1/41 (2.44%)  0/109 (0.00%)  1/23 (4.35%)  0/52 (0.00%)  0/18 (0.00%)  0/57 (0.00%) 
IgA nephropathy  1  0/41 (0.00%)  1/109 (0.92%)  0/23 (0.00%)  1/52 (1.92%)  0/18 (0.00%)  0/57 (0.00%) 
Lupus nephritis  1  3/41 (7.32%)  1/109 (0.92%)  3/23 (13.04%)  1/52 (1.92%)  0/18 (0.00%)  0/57 (0.00%) 
Nephrotic syndrome  1  0/41 (0.00%)  1/109 (0.92%)  0/23 (0.00%)  1/52 (1.92%)  0/18 (0.00%)  0/57 (0.00%) 
Neurogenic bladder  1  0/41 (0.00%)  1/109 (0.92%)  0/23 (0.00%)  1/52 (1.92%)  0/18 (0.00%)  0/57 (0.00%) 
Proteinuria  1  1/41 (2.44%)  0/109 (0.00%)  1/23 (4.35%)  0/52 (0.00%)  0/18 (0.00%)  0/57 (0.00%) 
Vascular disorders             
Hypertension  1  1/41 (2.44%)  0/109 (0.00%)  0/23 (0.00%)  0/52 (0.00%)  1/18 (5.56%)  0/57 (0.00%) 
Hypotension  1  0/41 (0.00%)  1/109 (0.92%)  0/23 (0.00%)  0/52 (0.00%)  0/18 (0.00%)  1/57 (1.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valsartan + Antihypertensive Group Valsartan Alone CKD Patients: Valsartan + Antihypertensive Group CKD Patients: Valsartan Alone Non-CKD Patients: Valsartan + Antihypertensive Group Non-CKD Patients: Valsartan Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/41 (82.93%)   68/109 (62.39%)   18/23 (78.26%)   36/52 (69.23%)   16/18 (88.89%)   32/57 (56.14%) 
Blood and lymphatic system disorders             
Lymphadenopathy  1  1/41 (2.44%)  0/109 (0.00%)  0/23 (0.00%)  0/52 (0.00%)  1/18 (5.56%)  0/57 (0.00%) 
Eye disorders             
Myopia  1  1/41 (2.44%)  1/109 (0.92%)  0/23 (0.00%)  0/52 (0.00%)  1/18 (5.56%)  1/57 (1.75%) 
Retinal vascular disorder  1  1/41 (2.44%)  0/109 (0.00%)  0/23 (0.00%)  0/52 (0.00%)  1/18 (5.56%)  0/57 (0.00%) 
Vision blurred  1  2/41 (4.88%)  0/109 (0.00%)  1/23 (4.35%)  0/52 (0.00%)  1/18 (5.56%)  0/57 (0.00%) 
Gastrointestinal disorders             
Abdominal pain  1  4/41 (9.76%)  7/109 (6.42%)  2/23 (8.70%)  4/52 (7.69%)  2/18 (11.11%)  3/57 (5.26%) 
Abdominal pain upper  1  2/41 (4.88%)  5/109 (4.59%)  2/23 (8.70%)  2/52 (3.85%)  0/18 (0.00%)  3/57 (5.26%) 
Constipation  1  1/41 (2.44%)  0/109 (0.00%)  0/23 (0.00%)  0/52 (0.00%)  1/18 (5.56%)  0/57 (0.00%) 
Diarrhoea  1  2/41 (4.88%)  8/109 (7.34%)  1/23 (4.35%)  5/52 (9.62%)  1/18 (5.56%)  3/57 (5.26%) 
Nausea  1  2/41 (4.88%)  3/109 (2.75%)  2/23 (8.70%)  2/52 (3.85%)  0/18 (0.00%)  1/57 (1.75%) 
Toothache  1  3/41 (7.32%)  1/109 (0.92%)  2/23 (8.70%)  0/52 (0.00%)  1/18 (5.56%)  1/57 (1.75%) 
Vomiting  1  5/41 (12.20%)  4/109 (3.67%)  4/23 (17.39%)  3/52 (5.77%)  1/18 (5.56%)  1/57 (1.75%) 
General disorders             
Asthenia  1  2/41 (4.88%)  1/109 (0.92%)  1/23 (4.35%)  0/52 (0.00%)  1/18 (5.56%)  1/57 (1.75%) 
Chest pain  1  1/41 (2.44%)  0/109 (0.00%)  0/23 (0.00%)  0/52 (0.00%)  1/18 (5.56%)  0/57 (0.00%) 
Pyrexia  1  12/41 (29.27%)  18/109 (16.51%)  8/23 (34.78%)  12/52 (23.08%)  4/18 (22.22%)  6/57 (10.53%) 
Infections and infestations             
Acarodermatitis  1  1/41 (2.44%)  1/109 (0.92%)  0/23 (0.00%)  1/52 (1.92%)  1/18 (5.56%)  0/57 (0.00%) 
Enterobiasis  1  1/41 (2.44%)  1/109 (0.92%)  0/23 (0.00%)  0/52 (0.00%)  1/18 (5.56%)  1/57 (1.75%) 
Influenza  1  3/41 (7.32%)  1/109 (0.92%)  1/23 (4.35%)  0/52 (0.00%)  2/18 (11.11%)  1/57 (1.75%) 
Mycoplasma infection  1  1/41 (2.44%)  0/109 (0.00%)  0/23 (0.00%)  0/52 (0.00%)  1/18 (5.56%)  0/57 (0.00%) 
Nasopharyngitis  1  11/41 (26.83%)  22/109 (20.18%)  7/23 (30.43%)  14/52 (26.92%)  4/18 (22.22%)  8/57 (14.04%) 
Pharyngitis  1  2/41 (4.88%)  0/109 (0.00%)  2/23 (8.70%)  0/52 (0.00%)  0/18 (0.00%)  0/57 (0.00%) 
Respiratory tract infection  1  2/41 (4.88%)  4/109 (3.67%)  1/23 (4.35%)  0/52 (0.00%)  1/18 (5.56%)  4/57 (7.02%) 
Rhinitis  1  0/41 (0.00%)  3/109 (2.75%)  0/23 (0.00%)  0/52 (0.00%)  0/18 (0.00%)  3/57 (5.26%) 
Upper respiratory tract infection  1  2/41 (4.88%)  17/109 (15.60%)  1/23 (4.35%)  12/52 (23.08%)  1/18 (5.56%)  5/57 (8.77%) 
Urinary tract infection  1  2/41 (4.88%)  3/109 (2.75%)  2/23 (8.70%)  2/52 (3.85%)  0/18 (0.00%)  1/57 (1.75%) 
Metabolism and nutrition disorders             
Hyperkalaemia  1  1/41 (2.44%)  4/109 (3.67%)  1/23 (4.35%)  4/52 (7.69%)  0/18 (0.00%)  0/57 (0.00%) 
Hyperphosphataemia  1  1/41 (2.44%)  0/109 (0.00%)  0/23 (0.00%)  0/52 (0.00%)  1/18 (5.56%)  0/57 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  1/41 (2.44%)  4/109 (3.67%)  1/23 (4.35%)  3/52 (5.77%)  0/18 (0.00%)  1/57 (1.75%) 
Neck pain  1  2/41 (4.88%)  0/109 (0.00%)  0/23 (0.00%)  0/52 (0.00%)  2/18 (11.11%)  0/57 (0.00%) 
Pain in extremity  1  3/41 (7.32%)  0/109 (0.00%)  2/23 (8.70%)  0/52 (0.00%)  1/18 (5.56%)  0/57 (0.00%) 
Nervous system disorders             
Dizziness  1  8/41 (19.51%)  17/109 (15.60%)  4/23 (17.39%)  6/52 (11.54%)  4/18 (22.22%)  11/57 (19.30%) 
Headache  1  14/41 (34.15%)  23/109 (21.10%)  8/23 (34.78%)  11/52 (21.15%)  6/18 (33.33%)  12/57 (21.05%) 
Hypoaesthesia  1  1/41 (2.44%)  1/109 (0.92%)  0/23 (0.00%)  1/52 (1.92%)  1/18 (5.56%)  0/57 (0.00%) 
Renal and urinary disorders             
Micturition urgency  1  1/41 (2.44%)  1/109 (0.92%)  0/23 (0.00%)  0/52 (0.00%)  1/18 (5.56%)  1/57 (1.75%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  18/41 (43.90%)  18/109 (16.51%)  12/23 (52.17%)  12/52 (23.08%)  6/18 (33.33%)  6/57 (10.53%) 
Dyspnoea  1  1/41 (2.44%)  2/109 (1.83%)  0/23 (0.00%)  2/52 (3.85%)  1/18 (5.56%)  0/57 (0.00%) 
Epistaxis  1  2/41 (4.88%)  1/109 (0.92%)  1/23 (4.35%)  0/52 (0.00%)  1/18 (5.56%)  1/57 (1.75%) 
Nasal congestion  1  3/41 (7.32%)  1/109 (0.92%)  1/23 (4.35%)  1/52 (1.92%)  2/18 (11.11%)  0/57 (0.00%) 
Oropharyngeal pain  1  2/41 (4.88%)  2/109 (1.83%)  1/23 (4.35%)  1/52 (1.92%)  1/18 (5.56%)  1/57 (1.75%) 
Rhinitis allergic  1  2/41 (4.88%)  0/109 (0.00%)  1/23 (4.35%)  0/52 (0.00%)  1/18 (5.56%)  0/57 (0.00%) 
Rhinorrhoea  1  4/41 (9.76%)  3/109 (2.75%)  3/23 (13.04%)  2/52 (3.85%)  1/18 (5.56%)  1/57 (1.75%) 
Skin and subcutaneous tissue disorders             
Acne  1  1/41 (2.44%)  2/109 (1.83%)  0/23 (0.00%)  1/52 (1.92%)  1/18 (5.56%)  1/57 (1.75%) 
Papule  1  1/41 (2.44%)  0/109 (0.00%)  0/23 (0.00%)  0/52 (0.00%)  1/18 (5.56%)  0/57 (0.00%) 
Pruritus  1  0/41 (0.00%)  3/109 (2.75%)  0/23 (0.00%)  3/52 (5.77%)  0/18 (0.00%)  0/57 (0.00%) 
Vascular disorders             
Hypertension  1  1/41 (2.44%)  0/109 (0.00%)  0/23 (0.00%)  0/52 (0.00%)  1/18 (5.56%)  0/57 (0.00%) 
Hypotension  1  2/41 (4.88%)  2/109 (1.83%)  2/23 (8.70%)  2/52 (3.85%)  0/18 (0.00%)  0/57 (0.00%) 
Pallor  1  1/41 (2.44%)  0/109 (0.00%)  0/23 (0.00%)  0/52 (0.00%)  1/18 (5.56%)  0/57 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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 (ie, 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: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01365481     History of Changes
Other Study ID Numbers: CVAL489K2305
2009-017594-37 ( EudraCT Number )
First Submitted: May 9, 2011
First Posted: June 3, 2011
Results First Submitted: March 9, 2016
Results First Posted: April 21, 2016
Last Update Posted: July 13, 2016