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Trial record 25 of 101 for:    AMLODIPINE AND VALSARTAN

Study of Efficacy and Safety of CVAA489 in Hypertensive Patients

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ClinicalTrials.gov Identifier: NCT02062645
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Essential Hypertension
Intervention Drug: amlodipine/valsartan
Enrollment 115
Recruitment Details One hundred thirty patients were screened and 115 were enrolled into the trial.
Pre-assignment Details  
Arm/Group Title Amlodipine/Valsartan
Hide Arm/Group Description All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
Period Title: Overall Study
Started 115
Completed 100
Not Completed 15
Reason Not Completed
Adverse Event             2
Protocol Violation             8
Lost to Follow-up             5
Arm/Group Title Amlodipine/Valsartan
Hide Arm/Group Description All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
The baseline population was the ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
55.06  (11.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
55
  55.0%
Male
45
  45.0%
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHG
Number Analyzed 100 participants
164.3  (13.2)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 100 participants
96.7  (12.7)
Heart rate  
Mean (Standard Deviation)
Unit of measure:  Beats/min
Number Analyzed 100 participants
80.15  (10.00)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 100 participants
31.19  (5.32)
1.Primary Outcome
Title Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Hide Description Control rate of BP defined as BP lower than 140/90 mmHg at office visits
Time Frame At week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values
Arm/Group Title Amlodipine/Valsartan
Hide Arm/Group Description:
All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 Systolic (n=100) 47.0
Week 4 Diastolic (n=100) 78.0
Week 4 Overall Blood Pressure(n=100) 45.0
Week 8 Systolic(n=91) 70.3
Week 8 Diastolic (n=91) 82.4
Week 8 Overall Blood Pressure (n=91) 67.0
Week 8 Systolic (LOCF) (n=100) 68.0
Week 8 Diastolic (LOCF) (n=100) 81.0
Week 8 Overall Blood Pressure (LOCF) (n=100) 65.0
2.Secondary Outcome
Title Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
Hide Description Change in systolic blood pressure measured in office from baseline at week 4 and 8.
Time Frame baseline, week 4, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values
Arm/Group Title Amlodipine/Valsartan
Hide Arm/Group Description:
All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic blood pressure (SBP) Day 0 (n=100) 164.3  (13.2)
Systolic blood pressure (SBP) Week 4 (n=100) 140.17  (14.05)
Systolic blood pressure (SBP) Week 8 (n=91) 134.04  (13.51)
Systolic blood pressure (SBP) Week 8 LOCF (n=100) 134.71  (13.37)
Decrease in Systolic Week 4 (n=100) 24.15  (18.18)
Decrease in Systolic Week 8 (n=91) 30.22  (18.25)
Decrease in Systolic BP Week 8 LOCF (n=100) 29.61  (17.81)
3.Secondary Outcome
Title Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
Hide Description Change in diastolic blood pressure measured in office from baseline at week 4 and week 8.
Time Frame baseline, week 4, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values
Arm/Group Title Amlodipine/Valsartan
Hide Arm/Group Description:
All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: mmHg
Diastolic blood pressure (DBP) Day 0 (n=100) 96.66  (12.68)
Diastolic blood pressure (DBP) Week 4 (n=100) 82.0  (9.88)
Diastolic blood pressure (DBP) Week 8 (n=91) 81.04  (8.66)
Diastolic blood pressure (DBP) Week 8 LOCF (n=100) 81.37  (8.69)
Decrease in Diastolic BP Week 4 (n=100) 14.66  (12.58)
Decrease in Diastolic BP Week 8 (n=91) 15.54  (13.19)
Decrease in Diastolic BP Week 8 LOCF (n=100) 15.29  (12.73)
4.Secondary Outcome
Title Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Hide Description Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (>100 mEq/day)
Time Frame At week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values
Arm/Group Title Amlodipine/Valsartan
Hide Arm/Group Description:
All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 (n=70) 68.6
Week 8 (n=64) 64.1
Week 8 LOCF (n=70) 62.9
5.Secondary Outcome
Title SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
Hide Description Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8.
Time Frame At week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
All patients received amlodipine/valsartan 160/5 mg daily at Day 0 and were up titrated to amlodipine/valsartan 160/10 mg daily at visit 2 (week 4) if their hypertension can not be controlled. The duration of treatment period was 8 weeks.
Arm/Group Title Amlodipine/Valsartan
Hide Arm/Group Description:
All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP at Week 4 (n=70) 140.01  (13.67)
SBP at Week 8 (n=64) 134.20  (13.24)
SBP at Week 8 LOCF (n=70) 134.84  (13.17)
DBP at Week 4 (n=70) 81.73  (10.26)
DBP at Week 8 (n=64) 81.23  (8.80)
DBP at Week 8 LOCF (n=70) 81.47  (8.91)
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population included data from patients who attended Visit 2 which was 110 patients.
 
Arm/Group Title Amlodipine/Valsartan
Hide Arm/Group Description amlodipine/valsartan
All-Cause Mortality
Amlodipine/Valsartan
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Amlodipine/Valsartan
Affected / at Risk (%)
Total   3/110 (2.73%) 
General disorders   
Death  1  1/110 (0.91%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1  1/110 (0.91%) 
Renal and urinary disorders   
Nephrolithiasis  1  1/110 (0.91%) 
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 2%
Amlodipine/Valsartan
Affected / at Risk (%)
Total   76/110 (69.09%) 
Blood and lymphatic system disorders   
Anaemia  1  7/110 (6.36%) 
Cardiac disorders   
Aortic valve incompetence  1  10/110 (9.09%) 
Diastolic dysfunction  1  5/110 (4.55%) 
Left atrial dilatation  1  4/110 (3.64%) 
Left ventricular dysfunction  1  34/110 (30.91%) 
Left ventricular hypertrophy  1  30/110 (27.27%) 
Mitral valve incompetence  1  16/110 (14.55%) 
Tricuspid valve incompetence  1  8/110 (7.27%) 
Gastrointestinal disorders   
Nausea  1  3/110 (2.73%) 
General disorders   
Oedema peripheral  1  3/110 (2.73%) 
Investigations   
Blood uric acid increased  1  3/110 (2.73%) 
Electrocardiogram abnormal  1  3/110 (2.73%) 
Urine sodium increased  1  8/110 (7.27%) 
Renal and urinary disorders   
Microalbuminuria  1  6/110 (5.45%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary hypertension  1  3/110 (2.73%) 
Vascular disorders   
Aortic aneurysm  1  4/110 (3.64%) 
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 (ie, data from all sites) in the clinical trial
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02062645     History of Changes
Other Study ID Numbers: CVAA489ATR04
First Submitted: February 12, 2014
First Posted: February 14, 2014
Results First Submitted: November 15, 2016
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017