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Trial record 15 of 99 for:    AMLODIPINE AND VALSARTAN

The Effects of Systolic Blood Pressure Lowering on Diastolic Function Using Valsartan + Amlodipine in Patients With Hypertension and Diastolic Dysfunction

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: NCT00523549
Recruitment Status : Completed
First Posted : August 31, 2007
Results First Posted : March 10, 2011
Last Update Posted : April 23, 2012
Sponsor:
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
Conditions Hypertension
Diastolic Dysfunction
Interventions Drug: valsartan
Drug: amlodipine
Enrollment 229
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intensive Treatment Regimen Standard Treatment Regimen
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(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.

(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.

Period Title: Overall Study
Started 114 115
Completed 95 99
Not Completed 19 16
Reason Not Completed
Adverse Event             6             3
Unsatisfactory therapeutic effect             0             1
Protocol Deviation             3             1
Patient withdrew consent             7             6
Lost to Follow-up             3             5
Arm/Group Title Intensive Treatment Regimen Standard Treatment Regimen Total
Hide Arm/Group Description

(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.

(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.

Total of all reporting groups
Overall Number of Baseline Participants 114 114 228
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 114 participants 228 participants
60.2  (10.03) 58.9  (9.45) 59.6  (9.74)
[1]
Measure Description: In this study, even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the Baseline Measures was performed using the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both the treatment arms).
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 114 participants 228 participants
Female
61
  53.5%
54
  47.4%
115
  50.4%
Male
53
  46.5%
60
  52.6%
113
  49.6%
[1]
Measure Description: In this study, even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the Baseline Measures was performed using the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both the treatment arms).
1.Primary Outcome
Title Change in Lateral Mitral Annular Myocardial Relaxation Velocity
Hide Description Change from baseline in lateral mitral annular myocardial relaxation velocity (E’) at Week 24
Time Frame Baseline to 24 weeks after treatment
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Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Intensive Treatment Regimen Standard Treatment Regimen
Hide Arm/Group Description:

(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.

(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.

Overall Number of Participants Analyzed 98 98
Mean (Standard Deviation)
Unit of Measure: cm/s
1.544  (1.3946) 1.476  (1.5985)
2.Secondary Outcome
Title Change in Left Atrial Size
Hide Description Change from baseline in left atrial size at Week 24
Time Frame Baseline to 24 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Intensive Treatment Regimen Standard Treatment Regimen
Hide Arm/Group Description:

(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.

(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.

Overall Number of Participants Analyzed 98 98
Mean (Standard Deviation)
Unit of Measure: cm
-0.127  (0.3082) -0.104  (0.2845)
3.Secondary Outcome
Title Change in Ratio of Peak E Wave Velocity/Lateral Mitral Annular Myocardial Relaxation Velocity
Hide Description Change from baseline in peak E-wave velocity / lateral mitral annular myocardial relaxation velocity (E/E’) at Week 24
Time Frame Baseline to 24 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Intensive Treatment Regimen Standard Treatment Regimen
Hide Arm/Group Description:

(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.

(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.

Overall Number of Participants Analyzed 98 98
Mean (Standard Deviation)
Unit of Measure: ratio
-0.951  (2.1729) -0.680  (2.0714)
4.Secondary Outcome
Title Percent Change From Baseline in Vascular Stiffness
Hide Description Percent change from baseline in Vascular Stiffness (measured by radial augmentation index [AI]) at Weeks 8 and 24
Time Frame Baseline to 8 and 24 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Intensive Treatment Regimen Standard Treatment Regimen
Hide Arm/Group Description:

(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.

(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.

Overall Number of Participants Analyzed 98 98
Mean (Standard Deviation)
Unit of Measure: percentage of change in mean AI
Week 8 -7.89  (9.645) -7.32  (11.970)
Week 24 -6.07  (10.582) -5.63  (11.367)
5.Secondary Outcome
Title Change in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description Change from baseline in msSBP at Weeks 8 and 24
Time Frame Baseline to 8 and 24 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Intensive Treatment Regimen Standard Treatment Regimen
Hide Arm/Group Description:

(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.

(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.

Overall Number of Participants Analyzed 98 98
Mean (Standard Deviation)
Unit of Measure: mm Hg
Week 8 -25.74  (16.112) -22.31  (16.014)
Week 24 -30.37  (18.745) -25.06  (17.074)
6.Secondary Outcome
Title Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description Change from baseline in msDBP at Weeks 8 and 24
Time Frame Baseline to 8 and 24 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Intensive Treatment Regimen Standard Treatment Regimen
Hide Arm/Group Description:

(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.

(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.

Overall Number of Participants Analyzed 98 98
Mean (Standard Deviation)
Unit of Measure: mm Hg
Week 8 -12.77  (10.118) -12.62  (10.475)
Week 24 -15.21  (10.147) -14.08  (11.163)
7.Secondary Outcome
Title Change in Estimated Central Aortic Pressure
Hide Description Change from baseline in estimated central aortic pressure at Weeks 8 and 24
Time Frame Baseline to 8 and 24 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Intensive Treatment Regimen Standard Treatment Regimen
Hide Arm/Group Description:

(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.

(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.

Overall Number of Participants Analyzed 98 98
Mean (Standard Deviation)
Unit of Measure: mm Hg
Week 8 -16.30  (12.483) -14.68  (12.751)
Week 24 -17.71  (14.635) -14.76  (12.689)
Time Frame 24 weeks
Adverse Event Reporting Description Even though the number of patients randomized to the intensive and standard treatment regimen were 114 and 115 respectively, analysis of the adverse events was performed in the Safety Population. The Safety Population included all randomized patients who received at least one dose of study medication (Number of patients= 114 in both treatment arms)
 
Arm/Group Title Intensive Treatment Regimen Standard Treatment Regimen
Hide Arm/Group Description

(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications.

(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.

At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications.

All-Cause Mortality
Intensive Treatment Regimen Standard Treatment Regimen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intensive Treatment Regimen Standard Treatment Regimen
Affected / at Risk (%) Affected / at Risk (%)
Total   3/114 (2.63%)   3/114 (2.63%) 
Cardiac disorders     
Atrial fibrillation  1  1/114 (0.88%)  0/114 (0.00%) 
Endocrine disorders     
Goitre  1  1/114 (0.88%)  0/114 (0.00%) 
Gastrointestinal disorders     
Appendicitis perforated  1  0/114 (0.00%)  1/114 (0.88%) 
Intestinal obstruction  1  0/114 (0.00%)  1/114 (0.88%) 
Pancreatitis  1  0/114 (0.00%)  1/114 (0.88%) 
Hepatobiliary disorders     
Cholecystitis acute  1  0/114 (0.00%)  1/114 (0.88%) 
Infections and infestations     
Abdominal abscess  1  0/114 (0.00%)  1/114 (0.88%) 
Pneumonia  1  0/114 (0.00%)  1/114 (0.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant melanoma  1  1/114 (0.88%)  0/114 (0.00%) 
Thyroid adenoma  1  1/114 (0.88%)  0/114 (0.00%) 
Nervous system disorders     
Dizziness  1  1/114 (0.88%)  0/114 (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%
Intensive Treatment Regimen Standard Treatment Regimen
Affected / at Risk (%) Affected / at Risk (%)
Total   49/114 (42.98%)   41/114 (35.96%) 
General disorders     
Fatigue  1  12/114 (10.53%)  7/114 (6.14%) 
Oedema peripheral  1  24/114 (21.05%)  20/114 (17.54%) 
Infections and infestations     
Upper respiratory tract infection  1  8/114 (7.02%)  7/114 (6.14%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  6/114 (5.26%)  4/114 (3.51%) 
Nervous system disorders     
Dizziness  1  16/114 (14.04%)  9/114 (7.89%) 
Headache  1  5/114 (4.39%)  8/114 (7.02%) 
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: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00523549     History of Changes
Other Study ID Numbers: CVAA489AUS01
First Submitted: August 30, 2007
First Posted: August 31, 2007
Results First Submitted: December 6, 2010
Results First Posted: March 10, 2011
Last Update Posted: April 23, 2012