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Trial record 24 of 99 for:    AMLODIPINE AND VALSARTAN

The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy (EXTRA)

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ClinicalTrials.gov Identifier: NCT00666536
Recruitment Status : Completed
First Posted : April 25, 2008
Results First Posted : December 10, 2010
Last Update Posted : October 27, 2016
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Intervention Drug: valsartan and amlodipine
Enrollment 728
Recruitment Details  
Pre-assignment Details 369 and 359 are the total randomized patients by treatment groups respectively. In the baseline measures tables 366 and 357 are the total patients for the ITT population by treatment group.
Arm/Group Title Aggressive Treatment Regimen (5/320 mg to 10/320 mg) Moderate Treatment Regimen (5/160 mg)
Hide Arm/Group Description Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Period Title: Overall Study
Started 369 359
Completed 336 322
Not Completed 33 37
Reason Not Completed
Adverse Event             9             19
Unsatisfactory therapeutic effect             2             0
Protocol deviation(s)             8             6
Withdrawal by Subject             10             9
Lost to Follow-up             4             3
Arm/Group Title Aggressive Treatment Regimen (5/320 mg to 10/320 mg) Moderate Treatment Regimen (5/160 mg) Total
Hide Arm/Group Description Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) Total of all reporting groups
Overall Number of Baseline Participants 366 357 723
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 366 participants 357 participants 723 participants
< 65 years 302 292 594
>=65 years 64 65 129
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 366 participants 357 participants 723 participants
54.4  (10.98) 55.0  (10.98) 54.7  (10.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 366 participants 357 participants 723 participants
Female
157
  42.9%
157
  44.0%
314
  43.4%
Male
209
  57.1%
200
  56.0%
409
  56.6%
1.Primary Outcome
Title Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT), Last observation carried forward (LOCF)
Arm/Group Title Aggressive Treatment Regimen (5/320 mg to 10/320 mg) Moderate Treatment Regimen (5/160 mg)
Hide Arm/Group Description:
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Overall Number of Participants Analyzed 366 357
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline MSSBP 163.9  (11.85) 163.3  (11.40)
Week 4 MSSBP 140.9  (14.61) 144.4  (14.21)
Change From Baseline to Week 4 in MSSBP -23.0  (14.60) -18.9  (13.92)
2.Secondary Outcome
Title Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12
Hide Description [Not Specified]
Time Frame Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT), Last observation carried forward (LOCF)
Arm/Group Title Aggressive Treatment Regimen (5/320 mg to 10/320 mg) Moderate Treatment Regimen (5/160 mg)
Hide Arm/Group Description:
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Overall Number of Participants Analyzed 366 357
Measure Type: Number
Unit of Measure: Percentage of Patients
Week 2 25.1 25.8
Week 4 43.7 31.1
Week 8 61.7 46.2
Week 12 59.8 50.7
3.Secondary Outcome
Title Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT), Last observation carried forward (LOCF)
Arm/Group Title Aggressive Treatment Regimen (5/320 mg to 10/320 mg) Moderate Treatment Regimen (5/160 mg)
Hide Arm/Group Description:
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Overall Number of Participants Analyzed 366 357
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline MSDBP 95.5  (11.19) 95.0  (10.33)
Week 4 MSDBP 84.8  (11.47) 86.2  (9.6)
Change From Baseline to Week 4 in MSDBP -10.7  (9.39) -8.8  (9.08)
4.Secondary Outcome
Title Change From Baseline to Weeks 2, 8 and 12 in MSSBP
Hide Description [Not Specified]
Time Frame Baseline and Weeks 2, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT), Last observation carried forward (LOCF)
Arm/Group Title Aggressive Treatment Regimen (5/320 mg to 10/320 mg) Moderate Treatment Regimen (5/160 mg)
Hide Arm/Group Description:
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Overall Number of Participants Analyzed 366 357
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline MSSBP 163.9  (11.85) 163.3  (11.40)
Week 2 MSSBP 147.0  (14.93) 146.0  (14.80)
Change From Baseline to Week 2 in MSSBP -16.9  (13.94) -17.3  (13.80)
Week 8 MSSBP 136.0  (15.27) 140.5  (15.91)
Change From Baseline to Week 8 in MSSBP -27.9  (16.08) -22.8  (16.15)
Week 12 MSSBP 135.7  (14.97) 139.2  (15.63)
Change From Baseline to Week 12 in MSSBP -28.1  (16.59) -24.1  (16.07)
5.Secondary Outcome
Title Change From Baseline to Weeks 2, 8 and 12 in MSDBP
Hide Description [Not Specified]
Time Frame Baseline and Weeks 2, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT), Last observation carried forward (LOCF)
Arm/Group Title Aggressive Treatment Regimen (5/320 mg to 10/320 mg) Moderate Treatment Regimen (5/160 mg)
Hide Arm/Group Description:
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Overall Number of Participants Analyzed 366 357
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline MSDBP 95.5  (11.19) 95.0  (10.33)
Week 2 MSDBP 88.2  (10.93) 87.1  (10.38)
Change From Baseline to Week 2 in MSDBP -7.3  (8.51) -7.9  (9.66)
Week 8 MSDBP 81.6  (11.15) 84.0  (11.39)
Change From Baseline to Week 8 in MSDBP -13.9  (9.97) -11.0  (10.33)
Week 12 MSDBP 81.5  (10.62) 83.8  (10.61)
Change From Baseline to Week 12 in MSDBP -14.0  (10.41) -11.2  (10.48)
6.Secondary Outcome
Title Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12
Hide Description [Not Specified]
Time Frame Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT), Last observation carried forward (LOCF)
Arm/Group Title Aggressive Treatment Regimen (5/320 mg to 10/320 mg) Moderate Treatment Regimen (5/160 mg)
Hide Arm/Group Description:
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Overall Number of Participants Analyzed 366 357
Measure Type: Number
Unit of Measure: Percentage of Patients
Week 2 31.1 32.5
Week 4 49.2 37.5
Week 8 66.1 49.6
Week 12 62.8 55.7
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aggressive Treatment Regimen (5/320 mg to 10/320 mg) Moderate Treatment Regimen (5/160 mg)
Hide Arm/Group Description Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
All-Cause Mortality
Aggressive Treatment Regimen (5/320 mg to 10/320 mg) Moderate Treatment Regimen (5/160 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aggressive Treatment Regimen (5/320 mg to 10/320 mg) Moderate Treatment Regimen (5/160 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/369 (1.08%)   10/359 (2.79%) 
Cardiac disorders     
Angina pectoris  1  0/369 (0.00%)  2/359 (0.56%) 
Cardiac arrest  1  0/369 (0.00%)  1/359 (0.28%) 
Cardiac failure congestive  1  0/369 (0.00%)  1/359 (0.28%) 
Myocardial infarction  1  0/369 (0.00%)  2/359 (0.56%) 
Palpitations  1  0/369 (0.00%)  1/359 (0.28%) 
Tachycardia  1  0/369 (0.00%)  1/359 (0.28%) 
Gastrointestinal disorders     
Abdominal pain  1  0/369 (0.00%)  2/359 (0.56%) 
Small intestinal obstruction  1  0/369 (0.00%)  1/359 (0.28%) 
General disorders     
Chest pain  1  1/369 (0.27%)  0/359 (0.00%) 
Gait disturbance  1  0/369 (0.00%)  1/359 (0.28%) 
Non-cardiac chest pain  1  0/369 (0.00%)  1/359 (0.28%) 
Infections and infestations     
Diverticulitis  1  0/369 (0.00%)  1/359 (0.28%) 
Pneumonia bacterial  1  0/369 (0.00%)  1/359 (0.28%) 
Investigations     
Electrocardiogram T wave abnormal  1  0/369 (0.00%)  1/359 (0.28%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  1/369 (0.27%)  0/359 (0.00%) 
Type 1 diabetes mellitus  1  1/369 (0.27%)  0/359 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/369 (0.00%)  1/359 (0.28%) 
Breast cancer in situ  1  1/369 (0.27%)  0/359 (0.00%) 
Nervous system disorders     
Balance disorder  1  0/369 (0.00%)  1/359 (0.28%) 
Hypoaesthesia  1  0/369 (0.00%)  1/359 (0.28%) 
Psychiatric disorders     
Depression  1  1/369 (0.27%)  0/359 (0.00%) 
Suicide attempt  1  1/369 (0.27%)  0/359 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/369 (0.00%)  1/359 (0.28%) 
Dyspnoea  1  0/369 (0.00%)  1/359 (0.28%) 
Orthopnoea  1  0/369 (0.00%)  1/359 (0.28%) 
Vascular disorders     
Hypertension  1  0/369 (0.00%)  1/359 (0.28%) 
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%
Aggressive Treatment Regimen (5/320 mg to 10/320 mg) Moderate Treatment Regimen (5/160 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   50/369 (13.55%)   29/359 (8.08%) 
General disorders     
Oedema peripheral  1  32/369 (8.67%)  16/359 (4.46%) 
Nervous system disorders     
Dizziness  1  19/369 (5.15%)  14/359 (3.90%) 
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, pharmaceuticals
ClinicalTrials.gov Identifier: NCT00666536     History of Changes
Other Study ID Numbers: CVAA489AUS02
First Submitted: April 23, 2008
First Posted: April 25, 2008
Results First Submitted: November 16, 2010
Results First Posted: December 10, 2010
Last Update Posted: October 27, 2016