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Trial record 56 of 134 for:    OLMESARTAN

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension

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ClinicalTrials.gov Identifier: NCT01599104
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : August 6, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Essential Hypertension
Interventions Drug: LCZ696
Drug: Olmesartan
Drug: Placebo
Enrollment 1161
Recruitment Details The study consisted of 3 epochs: 1)screening, 2) single blind run-in and 3) double blind treatment. During the run-in epoch, eligible participants received placebo to both treatments for 2 to 4 weeks. After the run-in epoch, a total of 1161 eligible participants continued into the double blind treatment epoch for 8 weeks.
Pre-assignment Details  
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
Period Title: Overall Study
Started 387 385 389
Completed 371 371 363
Not Completed 16 14 26
Reason Not Completed
Withdrawal by Subject             1             1             2
Technical Problems             1             0             0
Physician Decision             3             2             2
Non-compliance with study treatment             0             1             0
Lack of Efficacy             4             4             10
Adverse Event             7             6             12
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg Total
Hide Arm/Group Description LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 387 385 389 1161
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 387 participants 385 participants 389 participants 1161 participants
57.9  (10.87) 58.7  (10.50) 59.6  (10.50) 58.7  (10.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 387 participants 385 participants 389 participants 1161 participants
Female
123
  31.8%
117
  30.4%
103
  26.5%
343
  29.5%
Male
264
  68.2%
268
  69.6%
286
  73.5%
818
  70.5%
1.Primary Outcome
Title Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The full analysis set included all randomized participants who received study medication and had both baseline and post-baseline BP assessments.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 387 385 389
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-18.21  (0.702) -20.18  (0.704) -13.20  (0.700)
2.Secondary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8
Hide Description Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 216 216 200
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-13.44  (0.445) -14.99  (0.445) -8.78  (0.462)
3.Secondary Outcome
Title Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 387 385 389
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-7.76  (0.404) -8.79  (0.406) -5.91  (0.404)
4.Secondary Outcome
Title Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8
Hide Description A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 387 385 389
Measure Type: Number
Unit of Measure: Percentage of participants
43.9 46.5 32.9
5.Secondary Outcome
Title Percentage of Participants Achieving a Successful msSBP Response
Hide Description Successful msSBP response was defined as < 140 mmHg or ≥ 20 mmHg reduction from baseline.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 387 385 389
Measure Type: Number
Unit of Measure: Percentage of participants
57.9 63.1 42.9
6.Secondary Outcome
Title Percentage of Participants Achieving a Successful msDBP Response
Hide Description Successfull msDBP response was defined as <90 mmHg or ≥10 mmHg reduction from baseline.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 387 385 389
Measure Type: Number
Unit of Measure: Percentage of participants
69.5 70.1 60.7
7.Secondary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8
Hide Description ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 216 216 200
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-7.65  (0.295) -8.44  (0.295) -5.56  (0.307)
8.Secondary Outcome
Title Change From Baseline in maSBP and maDBP for Daytime/Nighttime
Hide Description ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 216 216 200
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
maSBP daytime -12.60  (0.747) -14.44  (0.747) -7.87  (0.776)
maSBP nighttime -15.13  (0.747) -16.09  (0.747) -10.65  (0.776)
maDBP daytime -7.01  (0.506) -8.00  (0.506) -4.95  (0.526)
maDBP nighttime -8.82  (0.506) -9.42  (0.506) -6.79  (0.526)
9.Secondary Outcome
Title Change From Baseline in Office Pulse Pressure
Hide Description Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 387 385 389
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-10.49  (0.471) -11.30  (0.472) -7.34  (0.470)
10.Secondary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure
Hide Description Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 216 216 200
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-5.79  (0.208) -6.57  (0.207) -3.20  (0.216)
11.Secondary Outcome
Title Number of Patients With Adverse Events, Serious Adverse Events and Death
Hide Description Participants were monitored for adverse events, serious adverse events and deaths throughout the study.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set. The safety set included aqll participants who had received study medication.
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description:
LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 387 385 389
Measure Type: Number
Unit of Measure: Participants
Adverse Events (serious and non-serious) 135 136 152
Seroius Adverse Events 1 1 7
Deaths 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Hide Arm/Group Description LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
All-Cause Mortality
LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/387 (0.26%)   1/385 (0.26%)   7/389 (1.80%) 
Cardiac disorders       
ARTERIOSCLEROSIS CORONARY ARTERY  1  0/387 (0.00%)  1/385 (0.26%)  0/389 (0.00%) 
SUPRAVENTRICULAR TACHYCARDIA  1  0/387 (0.00%)  0/385 (0.00%)  1/389 (0.26%) 
Eye disorders       
CATARACT  1  0/387 (0.00%)  0/385 (0.00%)  1/389 (0.26%) 
Hepatobiliary disorders       
BILE DUCT STONE  1  0/387 (0.00%)  0/385 (0.00%)  1/389 (0.26%) 
HEPATOBILIARY DISEASE  1  0/387 (0.00%)  1/385 (0.26%)  0/389 (0.00%) 
Injury, poisoning and procedural complications       
RADIUS FRACTURE  1  0/387 (0.00%)  0/385 (0.00%)  1/389 (0.26%) 
Investigations       
ALANINE AMINOTRANSFERASE INCREASED  1  0/387 (0.00%)  0/385 (0.00%)  1/389 (0.26%) 
Musculoskeletal and connective tissue disorders       
OSTEOARTHRITIS  1  0/387 (0.00%)  0/385 (0.00%)  1/389 (0.26%) 
Nervous system disorders       
CEREBRAL INFARCTION  1  0/387 (0.00%)  0/385 (0.00%)  1/389 (0.26%) 
SUBARACHNOID HAEMORRHAGE  1  1/387 (0.26%)  0/385 (0.00%)  0/389 (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 2%
LCZ696 200 mg LCZ696 400 mg Olmesartan 20 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   48/387 (12.40%)   47/385 (12.21%)   46/389 (11.83%) 
Infections and infestations       
NASOPHARYNGITIS  1  48/387 (12.40%)  47/385 (12.21%)  46/389 (11.83%) 
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 or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: +1 (862) 778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01599104     History of Changes
Other Study ID Numbers: CLCZ696A1306
First Submitted: May 13, 2012
First Posted: May 15, 2012
Results First Submitted: July 11, 2015
Results First Posted: August 6, 2015
Last Update Posted: October 16, 2015