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Trial record 10 of 100 for:    AMLODIPINE AND VALSARTAN

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

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ClinicalTrials.gov Identifier: NCT00523744
Recruitment Status : Completed
First Posted : August 31, 2007
Results First Posted : May 25, 2011
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Amlodipine
Drug: Olmesartan medoxomil
Drug: Amlodipine+valsartan
Drug: Hydrochlorothiazide
Enrollment 257
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ
Hide Arm/Group Description During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
Period Title: Phase 1 - Amlodipine+Olmesartan
Started 257
Completed 251
Not Completed 6
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             1
Lost to Follow-up             2
Administrative problems             1
Period Title: Phase 2 - Amlodipine+Valsartan
Started 176 [1]
Completed 173
Not Completed 3
Reason Not Completed
Adverse Event             2
Lost to Follow-up             1
[1]
Only patients with mean sitting diastolic BP ≥ 90 mmHg at the end of Phase 1 entered this phase.
Period Title: Phase 3 - Amlodipine+Valsartan+HCTZ
Started 91 [1]
Completed 91
Not Completed 0
[1]
Only patients with systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg at the end of Phase 2.
Arm/Group Title Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ
Hide Arm/Group Description During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
Overall Number of Baseline Participants 257
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 257 participants
Phase 1 - Amlodipine+olmesartan 58.8  (12.38)
Phase 2 - Amlodipine+valsartan 59.8  (11.84)
Phase 3 - Amlodipine+valsartan+HCTZ 60.9  (10.98)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 257 participants
Phase 1 - Amlodipine+olmesartan 112
Phase 1 - Amlodipine+olmesartan 145
Phase 2 - Amlodipine+valsartan 76
Phase 2 - Amlodipine+valsartan 100
Phase 3 - Amlodipine+valsartan+HCTZ 32
Phase 3 - Amlodipine+valsartan+HCTZ 59
1.Primary Outcome
Title Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Time Frame Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.
Arm/Group Title Amlodipine+Valsartan - Phase 2
Hide Arm/Group Description:
Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
Overall Number of Participants Analyzed 175
Mean (95% Confidence Interval)
Unit of Measure: mmHg
-9.13
(-10.19 to -8.06)
2.Primary Outcome
Title Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Time Frame Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.
Arm/Group Title Amlodipine+Valsartan+HCTZ - Phase 3
Hide Arm/Group Description:
Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
Overall Number of Participants Analyzed 91
Mean (95% Confidence Interval)
Unit of Measure: mmHg
-5.22
(-6.76 to -3.68)
3.Secondary Outcome
Title Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Time Frame Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.
Arm/Group Title Amlodipine+Valsartan - Phase 2
Hide Arm/Group Description:
Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
Overall Number of Participants Analyzed 175
Mean (95% Confidence Interval)
Unit of Measure: mmHg
-7.87
(-9.33 to -6.11)
4.Secondary Outcome
Title Change in Sitting Pulse Pressure During the Core Phase of the Study
Hide Description Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Time Frame Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.
Arm/Group Title Amlodipine+Valsartan - Phase 2
Hide Arm/Group Description:
Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
Overall Number of Participants Analyzed 175
Mean (95% Confidence Interval)
Unit of Measure: mmHg
1.26
(0.49 to 3.01)
5.Secondary Outcome
Title Change in Sitting Pulse Rate During the Core Phase of the Study
Hide Description Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Time Frame Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.
Arm/Group Title Amlodipine+Valsartan - Phase 2
Hide Arm/Group Description:
Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
Overall Number of Participants Analyzed 175
Mean (95% Confidence Interval)
Unit of Measure: BPM (beats per minute)
-1.93
(-3.06 to -0.79)
6.Secondary Outcome
Title Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study
Hide Description Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.
Time Frame Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.
Arm/Group Title Amlodipine+Valsartan - Phase 2
Hide Arm/Group Description:
Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
Overall Number of Participants Analyzed 175
Measure Type: Number
Unit of Measure: Percentage of participants
msSBP < 140 mmHg 44.6
msDBP < 90 mmHg 72.6
7.Secondary Outcome
Title Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study
Hide Description Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 (Week 8) compared to Baseline in Phase 2 (week 4) or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.
Time Frame Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.
Arm/Group Title Amlodipine+Valsartan - Phase 2
Hide Arm/Group Description:
Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
Overall Number of Participants Analyzed 175
Measure Type: Number
Unit of Measure: Percentage of participants
msSBP response 47.4
msDBP response 73.1
8.Secondary Outcome
Title Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study
Hide Description The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Time Frame Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.
Arm/Group Title Amlodipine+Valsartan+HCTZ - Phase 3
Hide Arm/Group Description:
Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
Overall Number of Participants Analyzed 91
Mean (95% Confidence Interval)
Unit of Measure: mmHg
-10.84
(-12.94 to -8.75)
9.Secondary Outcome
Title Change in Sitting Pulse Pressure During the Extension Phase of the Study
Hide Description Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Time Frame Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.
Arm/Group Title Amlodipine+Valsartan+HCTZ - Phase 3
Hide Arm/Group Description:
Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
Overall Number of Participants Analyzed 91
Mean (95% Confidence Interval)
Unit of Measure: mmHg
-5.62
(-7.74 to -3.50)
10.Secondary Outcome
Title Change in Sitting Pulse Rate During the Extension Phase of the Study
Hide Description Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Time Frame Baseline Phase 3 (Week 8) to end of Phase 3 (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.
Arm/Group Title Amlodipine+Valsartan+HCTZ - Phase 3
Hide Arm/Group Description:
Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
Overall Number of Participants Analyzed 91
Mean (95% Confidence Interval)
Unit of Measure: BPM (beats per minute)
0.09
(-1.36 to 1.54)
11.Secondary Outcome
Title Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study
Hide Description Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.
Time Frame Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.
Arm/Group Title Amlodipine+Valsartan+HCTZ - Phase 3
Hide Arm/Group Description:
Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
Overall Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: Percentage of participants
msSBP < 140 mmHg 59.3
msDBP < 90 mmHg 83.5
12.Secondary Outcome
Title Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study
Hide Description Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 3 compared to Baseline in Phase 3 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 3 compared to Baseline in Phase 3.
Time Frame Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.
Arm/Group Title Amlodipine+Valsartan+HCTZ - Phase 3
Hide Arm/Group Description:
Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
Overall Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: Percentage of participants
msSBP response 61.5
msDBP response 83.5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1 - Amlodipine+Olmesartan Phase 2 - Amlodipine+Valsartan Phase 3 - Amlodipine+Valsartan+HCTZ
Hide Arm/Group Description 4 weeks treatment with amlodipine 10 mg plus olmesartan 20 mg taken orally once daily in the morning. Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning. Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
All-Cause Mortality
Phase 1 - Amlodipine+Olmesartan Phase 2 - Amlodipine+Valsartan Phase 3 - Amlodipine+Valsartan+HCTZ
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase 1 - Amlodipine+Olmesartan Phase 2 - Amlodipine+Valsartan Phase 3 - Amlodipine+Valsartan+HCTZ
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/257 (0.39%)   0/176 (0.00%)   0/91 (0.00%) 
Ear and labyrinth disorders       
SUDDEN HEARING LOSS  1  1/257 (0.39%)  0/176 (0.00%)  0/91 (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%
Phase 1 - Amlodipine+Olmesartan Phase 2 - Amlodipine+Valsartan Phase 3 - Amlodipine+Valsartan+HCTZ
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/257 (0.00%)   0/176 (0.00%)   0/91 (0.00%) 
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: NCT00523744     History of Changes
Other Study ID Numbers: CVAA489ADE06
First Submitted: August 30, 2007
First Posted: August 31, 2007
Results First Submitted: January 10, 2011
Results First Posted: May 25, 2011
Last Update Posted: June 10, 2011