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Trial record 69 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension (EXALT)

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ClinicalTrials.gov Identifier: NCT00931710
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : February 4, 2011
Last Update Posted : March 7, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Stage 2 Systolic Hypertension
Interventions Drug: valsartan, amlodipine, HCTZ
Drug: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ
Enrollment 488
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valsartan/Amlodipine/HCTZ Losartan/HCTZ
Hide Arm/Group Description Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study. Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
Period Title: Overall Study
Started 241 247
Completed 207 209
Not Completed 34 38
Reason Not Completed
Adverse Event             16             10
Abnormal test procedure results             2             0
Unsatisfactory therapeutic effects             5             12
Patient withdrew consent             4             9
Lost to Follow-up             6             5
Protocol deviation             1             2
Arm/Group Title Valsartan/Amlodipine/HCTZ Losartan/HCTZ Total
Hide Arm/Group Description Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study. Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study. Total of all reporting groups
Overall Number of Baseline Participants 241 247 488
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 241 participants 247 participants 488 participants
55.0  (9.83) 57.1  (9.69) 56.1  (9.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 247 participants 488 participants
Female
102
  42.3%
111
  44.9%
213
  43.6%
Male
139
  57.7%
136
  55.1%
275
  56.4%
1.Primary Outcome
Title Change in Mean Sitting Systolic Blood Pressure After 6 Weeks
Hide Description To compare the change from baseline in mean sitting systolic blood pressure (MSSBP) after 6 weeks of valsartan/amlodipine-based regimen with a losartan-based regimen in patients with Stage 2 systolic hypertension.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last observation carried forward (LOCF).
Arm/Group Title Valsartan/Amlodipine/HCTZ Losartan/HCTZ
Hide Arm/Group Description:
Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
Overall Number of Participants Analyzed 241 247
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 166.8  (7.03) 168.5  (9.03)
Week 6 135.5  (16.26) 142.5  (18.89)
Change from Baseline to Week 6 -31.3  (15.87) -26.0  (16.62)
2.Secondary Outcome
Title Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks
Hide Description To compare the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last observation carried forward (LOCF).
Arm/Group Title Valsartan/Amlodipine/HCTZ Losartan/HCTZ
Hide Arm/Group Description:
Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
Overall Number of Participants Analyzed 241 247
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 98.6  (7.71) 97.6  (7.88)
Week 6 85.1  (10.05) 88.5  (11.36)
Change from Baseline to Week 6 -13.6  (9.48) -9.1  (10.03)
3.Secondary Outcome
Title Cumulative Percentage of Patients Achieving Blood Pressure Control
Hide Description To compare the percentage of patients achieving blood pressure control (defined as patients achieving MSSBP < 140 mmHg and MSDBP < 90 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.
Time Frame 3 and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Valsartan/Amlodipine/HCTZ Losartan/HCTZ
Hide Arm/Group Description:
Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
Overall Number of Participants Analyzed 241 247
Measure Type: Number
Unit of Measure: cumulative percentage of patients
Week 3 30.5 15.3
Week 6 61.5 47.1
4.Secondary Outcome
Title Cumulative Percentage of Treatment Responders
Hide Description To compare the percentage of treatment responders (defined as patients with MSSBP < 140 mmHg or demonstrating a decrease from baseline of ≥ 20 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.
Time Frame 3 and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Valsartan/Amlodipine/HCTZ Losartan/HCTZ
Hide Arm/Group Description:
Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
Overall Number of Participants Analyzed 241 247
Measure Type: Number
Unit of Measure: Cumulative percentage of responders
Week 3 65.3 34.3
Week 6 87.0 71.5
5.Secondary Outcome
Title Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks
Hide Description To compare the change from baseline in MSSBP and MSDBP after 12 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last observation carried forward (LOCF).
Arm/Group Title Valsartan/Amlodipine/HCTZ Losartan/HCTZ
Hide Arm/Group Description:
Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
Overall Number of Participants Analyzed 241 247
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline MSSBP 166.8  (7.03) 168.5  (9.03)
Week 12 MSSBP 130.8  (16.22) 134.3  (19.41)
Change in MSSBP from baseline to Week 12 -36.0  (16.08) -34.2  (17.69)
Baseline MSDBP 98.6  (7.71) 97.6  (7.88)
Week 12 MSDBP 82.5  (10.18) 82.5  (11.43)
Change in MSDBP from baseline to Week 12 -16.1  (9.91) -15.1  (10.57)
6.Secondary Outcome
Title Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit
Hide Description To assess the incidence of peripheral edema occurring with valsartan/amlodipine-based regimen versus losartan-based regimen in patients with Stage 2 systolic hypertension.
Time Frame 3, 6, 9 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Valsartan/Amlodipine/HCTZ Losartan/HCTZ
Hide Arm/Group Description:
Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
Overall Number of Participants Analyzed 241 247
Measure Type: Number
Unit of Measure: cumulative percentage of patients
Week 3 0.8 0.8
Week 6 0.8 0.8
Week 9 1.3 0.8
Week 12 2.9 4.5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valsartan / Amlodipine / HCTZ Losartan / HCTZ
Hide Arm/Group Description Valsartan / amlodipine / HCTZ Losartan / HCTZ
All-Cause Mortality
Valsartan / Amlodipine / HCTZ Losartan / HCTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Valsartan / Amlodipine / HCTZ Losartan / HCTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   1/241 (0.41%)   2/247 (0.81%) 
General disorders     
Non-cardiac chest pain  1  1/241 (0.41%)  0/247 (0.00%) 
Infections and infestations     
Urinary tract infection  1  0/241 (0.00%)  1/247 (0.40%) 
Nervous system disorders     
Dizziness  1  0/241 (0.00%)  1/247 (0.40%) 
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%
Valsartan / Amlodipine / HCTZ Losartan / HCTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   13/241 (5.39%)   8/247 (3.24%) 
Nervous system disorders     
Dizziness  1  13/241 (5.39%)  8/247 (3.24%) 
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: NCT00931710     History of Changes
Other Study ID Numbers: CVEA489AUS01
First Submitted: July 1, 2009
First Posted: July 2, 2009
Results First Submitted: January 13, 2011
Results First Posted: February 4, 2011
Last Update Posted: March 7, 2011