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Trial record 43 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

Valsartan Intensified Primary Care Reduction of Blood Pressure Study (VIPER-BP)

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ClinicalTrials.gov Identifier: NCT00902304
Recruitment Status : Completed
First Posted : May 15, 2009
Results First Posted : August 30, 2012
Last Update Posted : December 4, 2012
Sponsor:
Collaborator:
Baker IDI Heart and Diabetes Institute
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Valsartan and hydrochlorothiazide (HCTZ) - monotherapy
Drug: Valsartan and amlodipine
Drug: Usual care
Drug: Valsartan
Drug: Valsartan and hydrochlorothiazide (HCTZ) - combination arm
Enrollment 2337
Recruitment Details  
Pre-assignment Details 2337 patients were enrolled. 2185 received study medication during the 4 week run-in period. 1562 patients were randomized.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study. Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Period Title: Overall Study
Started 524 360 678
Completed 466 289 568
Not Completed 58 71 110
Reason Not Completed
Adverse Event             4             10             25
Investigator discretion             3             5             13
Lost to Follow-up             7             7             7
Protocol Violation             9             18             20
Withdrawal by Subject             32             22             43
includes pregnancy             3             9             2
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm) Total
Hide Arm/Group Description Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study. Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study. Total of all reporting groups
Overall Number of Baseline Participants 524 360 678 1562
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 524 participants 360 participants 678 participants 1562 participants
59  (12) 59  (12) 59  (12) 59  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 524 participants 360 participants 678 participants 1562 participants
Female
201
  38.4%
138
  38.3%
260
  38.3%
599
  38.3%
Male
323
  61.6%
222
  61.7%
418
  61.7%
963
  61.7%
1.Primary Outcome
Title Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target
Hide Description BP target groups were: <= 125/75mmHg, <= 130/80mmHg and <= 140/90mmHg. The BP target was based on the patient's clinical risk profile as specified by National Heart Foundation of Australia guidelines.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description:
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Overall Number of Participants Analyzed 504 339 649
Measure Type: Number
Unit of Measure: percentage of participants
27.4 33.0 37.9
2.Secondary Outcome
Title Change in Mean Sitting Systolic Blood Pressure
Hide Description The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description:
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Overall Number of Participants Analyzed 504 339 649
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
-10
(-11.3 to -8.8)
-11.6
(-13.1 to -10.0)
-14.4
(-15.5 to -13.2)
3.Secondary Outcome
Title Change in Mean Sitting Diastolic Blood Pressure
Hide Description The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description:
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Overall Number of Participants Analyzed 504 339 649
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
-5.45
(-6.2 to -4.7)
-6.9
(-7.9 to -5.9)
-8.29
(-9.0 to -7.6)
4.Secondary Outcome
Title Change in Absolute Cardiovascular Risk Score
Hide Description

The absolute cardiovascular risk assessment uses the Framingham Risk Equation to predict risk of a cardiovascular event over the next 5 years. A score of <10% is a low risk, 10 to 15% is a moderate risk, and >15% is a high risk.

A decrease indicates improvement.

Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description:
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Overall Number of Participants Analyzed 397 252 492
Mean (Standard Deviation)
Unit of Measure: percentage risk score change
-2.6  (4.5) -3.3  (4.6) -3.9  (4.5)
5.Secondary Outcome
Title Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy
Hide Description The rate of all adverse events by preferred terms as determined by the General Practice investigators to be related to study intervention therapy was reported. Percentage of adverse events was calculated based on the number of participants analyzed. 41 adverse events were not reported as inadequate information was supplied to allow determination of drug treatment at onset.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis - consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description:
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Overall Number of Participants Analyzed 524 360 678
Measure Type: Number
Unit of Measure: participants
70 70 169
6.Secondary Outcome
Title Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments
Hide Description A comparison of the early responders was made based on the blood pressure measurements taken at the week 6 visit window according to gender and guideline targets. The guideline targets were: patients with renal impairment: 125/75 mmHg; patients with end-organ damage/cardiovascular disease: 130/80 mmHg; others: 140/90 mmHg.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description:
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Overall Number of Participants Analyzed 524 360 678
Measure Type: Number
Unit of Measure: Participants
Male patients with a target of <125/75 mmHg 3 3 6
Male patients with a target of <130/80 mmHg 27 14 34
Male patients with a target of <140/90 mmHg 31 22 48
Female patients with a target of <125/75 mmHg 2 2 2
Female patients with a target of <130/80 mmHg 16 5 34
Female patients with a target of <140/90 mmHg 18 11 42
7.Secondary Outcome
Title Change in the EQ-5D Score
Hide Description The EQ-5D total indexed score (AUS) measures self-reported quality of life with the following 5 dimensions: mobility (range 1,2,3), self-care (range 1,2,3), usual activity (range 1,2,3), pain/discomfort (range 1,2,3) and anxiety/depression (range 1,2,3), where a 1 indicates no problems, a 2 indicates moderate problems, and a 3 indicates severe problems. The range of possible utility scores are between -0.217 (derived from worse responses from all 5 dimensions with severe problems ie 3,3,3,3,3) and 1.000 (no problems for all 5 dimensions) for each dimension. An increase in EQ-5D indexed score (AUS) indicates improvement.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description:
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Overall Number of Participants Analyzed 406 264 511
Mean (95% Confidence Interval)
Unit of Measure: change in EQ-5D score
-0.007
(-0.022 to 0.008)
0.017
(-0.001 to 0.036)
0.011
(-0.003 to 0.024)
8.Secondary Outcome
Title Number of Patients With Depression
Hide Description Patients with depression refers to potential depressive symptoms, not clinically diagnosed depression. The 2 question Arrol screening tool was used to determine if the patient had potential depressive symptoms. The 2 questions are: During the last month have you often been bothered by feeling down, depressed or hopeless? During the past month have you often been bothered by little interest or pleasure in doing things? The presence of potential depressive symptoms was determined by a 'yes' answer to either of these questions.
Time Frame Baseline and week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description:
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Overall Number of Participants Analyzed 458 285 547
Measure Type: Number
Unit of Measure: participants
Baseline 154 96 185
Week 26 129 78 151
9.Secondary Outcome
Title Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26
Hide Description

The CES-D score was from 0 to 30, with a higher score indicating a higher level of depression.

The categories for the score are: 0 to 9 suggests no depression; 10 to 15 suggests mild depression; 16 to 24 suggests moderate depression; 24 or above suggests severe depression.

Time Frame Baseline and week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description:
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Overall Number of Participants Analyzed 88 49 93
Mean (Standard Deviation)
Unit of Measure: change in CES-D score
1.03  (9.24) -1.12  (10.95) 1.19  (11.09)
10.Secondary Outcome
Title Participants With End Organ Disease at Baseline and Week 26
Hide Description

A patient was considered to have end organ damage with either of the following: 1) proteinuria (dipstick = 1+ or more or protein/creatinine ratio > 30mg/mol or 24h urine protein > 0.3g); 2) no proteinuria, but presence of microalbuminuria (urine albumin/creatinine ratio 3.6 to 25mg/mol(male) or 3.6 to 35mg/mol (female) detected; 3) no proteinuria or microalbuminuria, but presence of macroalbuminuria (urine albumin/creatinine ratio > 25mg/mol(male) or >35mg/mol (female) detected OR 4) ECG evidence of LVH (Sokolow-Lyon voltage criteria values >= 38mm).

Baseline potential for end organ damage was calculated in all 1562 randomised patients based on the criteria outlined above. If no investigation/data available, assumed no end-organ damage.

It is important to note that given the limited number of ECGs at 26 weeks, between group comparisons should be limited to the two time points (baseline and 26 weeks).

Time Frame Baseline and week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description:
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Overall Number of Participants Analyzed 524 360 678
Measure Type: Number
Unit of Measure: participants
Baseline 226 146 315
Week 26 (N = 433, 277, 536) 157 88 177
11.Secondary Outcome
Title Change in Self-care Behavior Score From Baseline to Week 26
Hide Description A modified self-care behavior tool (questionnaire) was used to calculate 2 domain scales: maintenance and confidence. Each domain has a standardized score between 0 and 100. Self-care is best represented by maintenance. Confidence is an important process that moderates the relationship between self-care and outcomes. Higher index score suggests better self-care. A score of 70 or greater can be used as the cut-point to judge self-care adequacy.
Time Frame Baseline and week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description:
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Overall Number of Participants Analyzed 426 273 523
Mean (Standard Deviation)
Unit of Measure: Change in score
Maintenance score 2.59  (13.56) 2.27  (12.56) 3.17  (12.38)
Confidence score (N = 422, 269, 520) 0.93  (21.04) -0.72  (20.04) -0.71  (20.16)
12.Secondary Outcome
Title Rate of Treatment Compliance
Hide Description The rate of compliance was planned to be estimated from the quantity of unused medication returned at each scheduled visit over the entire follow-up period. Rate of compliance = (tablets supplied - tablets returned)/(tablets for 100% compliance).
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This data will not be analyzed due to the poor quality of the data.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description:
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Number of Patients With Major Clinical Endpoints
Hide Description Major clinical endpoints measured were all-cause mortality and fatal and non-fatal cardiovascular events (e.g. acute myocardial infarction, stroke and heart failure).
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.
Arm/Group Title Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description:
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Overall Number of Participants Analyzed 524 360 678
Measure Type: Number
Unit of Measure: participants
All-cause mortality 0 1 0
Non-fatal cardiovascular events 15 6 13
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pre-randomization Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Hide Arm/Group Description Pre-randomization Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study. Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
All-Cause Mortality
Pre-randomization Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pre-randomization Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   27/2185 (1.24%)   24/524 (4.58%)   15/360 (4.17%)   22/678 (3.24%) 
Blood and lymphatic system disorders         
Pancytopenia  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Cardiac disorders         
Acute myocardial infarction  1  1/2185 (0.05%)  1/524 (0.19%)  1/360 (0.28%)  0/678 (0.00%) 
Angina pectoris  1  1/2185 (0.05%)  3/524 (0.57%)  1/360 (0.28%)  0/678 (0.00%) 
Angina unstable  1  0/2185 (0.00%)  0/524 (0.00%)  1/360 (0.28%)  0/678 (0.00%) 
Atrial fibrillation  1  0/2185 (0.00%)  1/524 (0.19%)  1/360 (0.28%)  0/678 (0.00%) 
Cardiac failure  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Chest discomfort  1  0/2185 (0.00%)  2/524 (0.38%)  0/360 (0.00%)  0/678 (0.00%) 
Chest pain  1  2/2185 (0.09%)  1/524 (0.19%)  1/360 (0.28%)  5/678 (0.74%) 
Coronary artery disease  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Dizziness  1  1/2185 (0.05%)  1/524 (0.19%)  0/360 (0.00%)  1/678 (0.15%) 
Dyspnoea  1  0/2185 (0.00%)  3/524 (0.57%)  1/360 (0.28%)  4/678 (0.59%) 
Myocardial infarction  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Pericarditis  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Pulmonary oedema  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Supraventricular tachycardia  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Syncope  1  1/2185 (0.05%)  2/524 (0.38%)  0/360 (0.00%)  0/678 (0.00%) 
Endocrine disorders         
Hyperparathyroidism  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Gastrointestinal disorders         
Diarrhoea  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Diverticular perforation  1  0/2185 (0.00%)  0/524 (0.00%)  1/360 (0.28%)  0/678 (0.00%) 
Enlarged uvula  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Gastrointestinal haemorrhage  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Gastrooesophageal reflux disease  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Melaena  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Nausea  1  1/2185 (0.05%)  1/524 (0.19%)  1/360 (0.28%)  0/678 (0.00%) 
Pancreatitis  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Rectal polyp  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Small intestinal obstruction  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Vomiting  1  1/2185 (0.05%)  1/524 (0.19%)  0/360 (0.00%)  1/678 (0.15%) 
General disorders         
Oedema peripheral  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  2/678 (0.29%) 
Pseudocyst  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Pyrexia  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Infections and infestations         
Appendicitis  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Arthritis infective  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Cellulitis  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Infection  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Lower respiratory tract infection  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Otitis media  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Pilonidal cyst  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Pneumonia  1  1/2185 (0.05%)  1/524 (0.19%)  1/360 (0.28%)  1/678 (0.15%) 
Post procedural infection  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Injury, poisoning and procedural complications         
Ankle fracture  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Fall  1  2/2185 (0.09%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Femur fracture  1  0/2185 (0.00%)  0/524 (0.00%)  1/360 (0.28%)  0/678 (0.00%) 
Fibula fracture  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Meniscus lesion  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Overdose  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Investigations         
Biopsy prostate  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Blood test abnormal  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Liver function test abnormal  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Vitamin B12 increased  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Hyponatraemia  1  0/2185 (0.00%)  0/524 (0.00%)  1/360 (0.28%)  0/678 (0.00%) 
Musculoskeletal and connective tissue disorders         
Neck mass  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Pain in extremity  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Rotator cuff syndrome  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma  1  0/2185 (0.00%)  0/524 (0.00%)  1/360 (0.28%)  0/678 (0.00%) 
Brain neoplasm  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Breast cancer  1  0/2185 (0.00%)  0/524 (0.00%)  1/360 (0.28%)  0/678 (0.00%) 
Cystosarcoma phyllodes  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Lung neoplasm malignant  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Prostate cancer  1  0/2185 (0.00%)  0/524 (0.00%)  1/360 (0.28%)  1/678 (0.15%) 
Tongue neoplasm malignant stage unspecified  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Nervous system disorders         
Exertional headache  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Transient ischaemic attack  1  2/2185 (0.09%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Psychiatric disorders         
Anxiety  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Bipolar disorder  1  0/2185 (0.00%)  0/524 (0.00%)  1/360 (0.28%)  0/678 (0.00%) 
Delusion  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Drug abuse  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Intentional drug misuse  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Post-traumatic stress disorder  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Renal and urinary disorders         
Chromaturia  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Reproductive system and breast disorders         
Breast mass  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/2185 (0.00%)  0/524 (0.00%)  2/360 (0.56%)  0/678 (0.00%) 
Pleural effusion  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Productive cough  1  0/2185 (0.00%)  2/524 (0.38%)  0/360 (0.00%)  0/678 (0.00%) 
Skin and subcutaneous tissue disorders         
Angioedema  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Hyperhidrosis  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Rash pruritic  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Surgical and medical procedures         
Arthroscopic surgery  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Bladder neoplasm surgery  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Knee arthroplasty  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Nephrectomy  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Umbilical hernia repair  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Vascular disorders         
Haemorrhage  1  0/2185 (0.00%)  0/524 (0.00%)  0/360 (0.00%)  1/678 (0.15%) 
Hypertension  1  1/2185 (0.05%)  0/524 (0.00%)  0/360 (0.00%)  0/678 (0.00%) 
Hypertensive crisis  1  0/2185 (0.00%)  1/524 (0.19%)  0/360 (0.00%)  0/678 (0.00%) 
Orthostatic hypotension  1  0/2185 (0.00%)  0/524 (0.00%)  1/360 (0.28%)  0/678 (0.00%) 
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%
Pre-randomization Usual Care Monotherapy (Initial Monotherapy Arm) Combination (Initial Combination Therapy Arm)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   95/2185 (4.35%)   47/524 (8.97%)   36/360 (10.00%)   105/678 (15.49%) 
Cardiac disorders         
Dizziness  1  77/2185 (3.52%)  23/524 (4.39%)  28/360 (7.78%)  42/678 (6.19%) 
General disorders         
Oedema peripheral  1  20/2185 (0.92%)  27/524 (5.15%)  9/360 (2.50%)  67/678 (9.88%) 
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
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00902304     History of Changes
Other Study ID Numbers: CVAL489AAU01
First Submitted: April 28, 2009
First Posted: May 15, 2009
Results First Submitted: July 29, 2012
Results First Posted: August 30, 2012
Last Update Posted: December 4, 2012