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Trial record 41 of 99 for:    AMLODIPINE AND VALSARTAN

Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg (EXPLOR)

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ClinicalTrials.gov Identifier: NCT00687973
Recruitment Status : Completed
First Posted : June 2, 2008
Results First Posted : January 21, 2011
Last Update Posted : March 11, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Valsartan/amlodipine 80/5 mg tablets
Drug: Amlodipine 5 mg capsules
Drug: Amlodipine 10 mg capsules
Drug: Atenolol 50 mg tablets
Drug: Atenolol 100 mg tablets
Enrollment 393
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Hide Arm/Group Description Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled. Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Period Title: Overall Study
Started 193 200
Completed 169 162
Not Completed 24 38
Reason Not Completed
Adverse Event             18             28
Lack of Efficacy             2             3
Protocol Violation             1             2
Administrative Reasons             0             2
Withdrawal by Subject             3             3
Arm/Group Title Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg Total
Hide Arm/Group Description Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled. Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled. Total of all reporting groups
Overall Number of Baseline Participants 193 200 393
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 193 participants 200 participants 393 participants
57.5  (9.94) 56.2  (11.09) 56.9  (10.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants 200 participants 393 participants
Female
82
  42.5%
101
  50.5%
183
  46.6%
Male
111
  57.5%
99
  49.5%
210
  53.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 193 participants 200 participants 393 participants
193 200 393
1.Primary Outcome
Title Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)
Arm/Group Title Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Hide Arm/Group Description:
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Overall Number of Participants Analyzed 176 178
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-13.65  (1.15) -9.7  (1.09)
2.Secondary Outcome
Title Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)
Hide Description [Not Specified]
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)
Arm/Group Title Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Hide Arm/Group Description:
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Overall Number of Participants Analyzed 183 189
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-10.92  (1.18) -8.3  (1.12)
3.Secondary Outcome
Title Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)
Arm/Group Title Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Hide Arm/Group Description:
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Overall Number of Participants Analyzed 176 178
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-5.5  (0.65) -1.7  (0.63)
4.Secondary Outcome
Title Change From Baseline of Augmentation Index (Aix) at Week 8
Hide Description To calculate the blood pressure augmentation index, the inflection point of the pressure curve corresponding to the return of the reflection wave was determined. The ratio between the pressure located above and below the inflection point was calculated.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)
Arm/Group Title Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Hide Arm/Group Description:
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Overall Number of Participants Analyzed 181 187
Least Squares Mean (Standard Error)
Unit of Measure: Ratio
-2.21  (0.78) 3.61  (0.76)
5.Secondary Outcome
Title Change From Baseline of Aix at Week 24
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)
Arm/Group Title Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Hide Arm/Group Description:
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Overall Number of Participants Analyzed 175 178
Least Squares Mean (Standard Error)
Unit of Measure: Ratio
-4.10  (0.72) 2.40  (0.70)
6.Secondary Outcome
Title Change From Baseline of Aix Corrected to Heart Rate at Week 24
Hide Description The heart rate correction was computed by a multivariate model analysis
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)
Arm/Group Title Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Hide Arm/Group Description:
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Overall Number of Participants Analyzed 169 170
Least Squares Mean (Standard Error)
Unit of Measure: Ratio
-4.12  (0.67) -2.43  (0.66)
7.Secondary Outcome
Title Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)
Arm/Group Title Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Hide Arm/Group Description:
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Overall Number of Participants Analyzed 139 147
Least Squares Mean (Standard Error)
Unit of Measure: m/s
-0.98  (0.18) -0.95  (0.17)
8.Secondary Outcome
Title Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)
Hide Description Applanation tonometry is a measurement of aortic pressure and vascular stiffness. To assess the central aortic blood pressure, it is necessary to calibrate the applanation tonometry device using the brachial blood pressure.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Hide Arm/Group Description:
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Overall Number of Participants Analyzed 176 176
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
SBP -12.93  (1.14) -11.78  (1.11)
DBP -7.85  (0.70) -7.94  (0.68)
9.Secondary Outcome
Title Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Hide Arm/Group Description:
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Overall Number of Participants Analyzed 176 176
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-5.02  (0.72) -3.66  (0.70)
10.Secondary Outcome
Title Change From Baseline of SBP/DBP at Week 24 (Office BP)
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Hide Arm/Group Description:
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Overall Number of Participants Analyzed 183 185
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
SBP -14.49  (1.08) -16.94  (1.07)
DBP -8.17  (0.72) -10.45  (0.71)
11.Secondary Outcome
Title Change From Baseline of Pulse Pressure at Week 24 (Office BP)
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Hide Arm/Group Description:
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Overall Number of Participants Analyzed 183 185
Least Squares Mean (Standard Deviation)
Unit of Measure: mmHg
-6.32  (0.81) -6.48  (0.81)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amlodipine 5 mg Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Hide Arm/Group Description Run-in: Amlodipine 5 mg Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled. Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
All-Cause Mortality
Amlodipine 5 mg Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Amlodipine 5 mg Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/393 (0.76%)   4/193 (2.07%)   4/200 (2.00%) 
Gastrointestinal disorders       
Colitis ulcerative  1  0/393 (0.00%)  1/193 (0.52%)  0/200 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  1/393 (0.25%)  0/193 (0.00%)  0/200 (0.00%) 
Injury, poisoning and procedural complications       
Head injury  1  0/393 (0.00%)  0/193 (0.00%)  1/200 (0.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lip and/or oral cavity cancer  1  0/393 (0.00%)  1/193 (0.52%)  0/200 (0.00%) 
Neoplasm malignant  1  0/393 (0.00%)  0/193 (0.00%)  1/200 (0.50%) 
Pregnancy, puerperium and perinatal conditions       
Pregnancy  1  0/393 (0.00%)  0/193 (0.00%)  1/200 (0.50%) 
Psychiatric disorders       
Suicide attempt  1  0/393 (0.00%)  0/193 (0.00%)  1/200 (0.50%) 
Renal and urinary disorders       
Renal colic  1  1/393 (0.25%)  0/193 (0.00%)  0/200 (0.00%) 
Renal failure  1  1/393 (0.25%)  0/193 (0.00%)  0/200 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  0/393 (0.00%)  1/193 (0.52%)  0/200 (0.00%) 
Surgical and medical procedures       
Cholecystectomy  1  1/393 (0.25%)  0/193 (0.00%)  0/200 (0.00%) 
Cyst removal  1  0/393 (0.00%)  1/193 (0.52%)  0/200 (0.00%) 
Inguinal hernia repair  1  0/393 (0.00%)  0/193 (0.00%)  1/200 (0.50%) 
Joint arthroplasty  1  0/393 (0.00%)  1/193 (0.52%)  0/200 (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%
Amlodipine 5 mg Valsartan/Amlodipine 160/10 mg Atenolol/Amlodipine 100/10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/393 (2.54%)   30/193 (15.54%)   31/200 (15.50%) 
General disorders       
Oedema peripheral  1  10/393 (2.54%)  30/193 (15.54%)  31/200 (15.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However,Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00687973     History of Changes
Other Study ID Numbers: CVAA489AFR02
First Submitted: March 20, 2008
First Posted: June 2, 2008
Results First Submitted: December 22, 2010
Results First Posted: January 21, 2011
Last Update Posted: March 11, 2011