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Trial record 16 of 134 for:    OLMESARTAN

Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01876368
Recruitment Status : Completed
First Posted : June 12, 2013
Results First Posted : December 7, 2015
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: LCZ696
Drug: Olmesartan
Drug: Placebo of LCZ696
Drug: Placebo of Olmesartan
Enrollment 376
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Period Title: Overall Study
Started 188 188
Full Analysis Set (FAS) 188 187 [1]
Safety Set (SAF) 188 187
Completed 179 175
Not Completed 9 13
Reason Not Completed
Adverse Event             2             5
Lack of Efficacy             1             0
Lost to Follow-up             0             1
Non-compliance with study treatment             0             1
Physician Decision             0             2
Protocol deviation             3             3
Subject/guardian decision             3             1
[1]
One patient was not included in the SAF and FAS due to mis-randomization.
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg Total
Hide Arm/Group Description Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 188 187 375
Hide Baseline Analysis Population Description
Subject demographics and background characteristics by treatment group (Full analysis set)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 188 participants 187 participants 375 participants
57.1  (10.19) 58.0  (9.09) 57.6  (9.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 187 participants 375 participants
Female
91
  48.4%
92
  49.2%
183
  48.8%
Male
97
  51.6%
95
  50.8%
192
  51.2%
1.Primary Outcome
Title Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)
Hide Description Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description:
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Overall Number of Participants Analyzed 167 164
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-4.26  (0.60) -1.04  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCZ696 200 mg, Olmesartan 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.19
Confidence Interval (2-Sided) 95%
-4.73 to -1.65
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.78
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)
Hide Description Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description:
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Overall Number of Participants Analyzed 167 164
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-2.27  (0.39) -0.35  (0.39)
3.Secondary Outcome
Title Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Hide Description Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description:
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Overall Number of Participants Analyzed 188 187
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-14.21  (1.28) -10.03  (1.29)
4.Secondary Outcome
Title Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description:
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Overall Number of Participants Analyzed 188 187
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-7.52  (0.70) -4.47  (0.71)
5.Secondary Outcome
Title Change From Baseline in Office Pulse Pressure
Hide Description Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description:
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Overall Number of Participants Analyzed 188 187
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-6.67  (0.94) -5.54  (0.94)
6.Secondary Outcome
Title Number of Patients Achieving Successful Overall Blood Pressure Control
Hide Description Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description:
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Overall Number of Participants Analyzed 188 187
Measure Type: Number
Unit of Measure: Participants
76 52
7.Secondary Outcome
Title Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control
Hide Description Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description:
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Overall Number of Participants Analyzed 188 187
Measure Type: Number
Unit of Measure: Participants
84 58
8.Secondary Outcome
Title Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control
Hide Description Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description:
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Overall Number of Participants Analyzed 188 187
Measure Type: Number
Unit of Measure: Participants
133 112
9.Secondary Outcome
Title Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response
Hide Description Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description:
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Overall Number of Participants Analyzed 188 187
Measure Type: Number
Unit of Measure: Participants
90 65
10.Secondary Outcome
Title Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response
Hide Description Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction ≥10 mmHg from baseline.
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description:
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Overall Number of Participants Analyzed 188 187
Measure Type: Number
Unit of Measure: Participants
137 115
11.Secondary Outcome
Title Number of Patients With Total Adverse Events, Serious Adverse Events and Death
Hide Description Number of patients with total adverse events, serious adverse events and death were reported.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SAF) - All patients who received at least one dose of study medication in the double-blind epoch. Patients were analyzed according to the treatment they received. One patient was not included in the SAF due to mis-randomization.
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description:
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Overall Number of Participants Analyzed 188 187
Measure Type: Number
Unit of Measure: Number of participants
Adverse events (serious and non-serious) 44 41
Serious Adverse Events 0 2
Deaths 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LCZ696 200 mg Olmesartan 20 mg
Hide Arm/Group Description Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
All-Cause Mortality
LCZ696 200 mg Olmesartan 20 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LCZ696 200 mg Olmesartan 20 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/188 (0.00%)   2/187 (1.07%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BENIGN NEOPLASM OF THYROID GLAND  1  0/188 (0.00%)  1/187 (0.53%) 
Nervous system disorders     
CEREBROVASCULAR ACCIDENT  1  0/188 (0.00%)  1/187 (0.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
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 Olmesartan 20 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   7/188 (3.72%)   10/187 (5.35%) 
Nervous system disorders     
DIZZINESS  1  2/188 (1.06%)  4/187 (2.14%) 
HEADACHE  1  5/188 (2.66%)  6/187 (3.21%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
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: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01876368     History of Changes
Other Study ID Numbers: CLCZ696A2318
2013-001783-36 ( EudraCT Number )
First Submitted: June 9, 2013
First Posted: June 12, 2013
Results First Submitted: July 29, 2015
Results First Posted: December 7, 2015
Last Update Posted: December 7, 2015