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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01615198
First received: June 6, 2012
Last updated: July 20, 2015
Last verified: July 2015

June 6, 2012
July 20, 2015
August 2012
July 2013   (final data collection date for primary outcome measure)
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.
Change from baseline in mean sitting systolic blood pressure (msSBP) [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
Sitting BP measurements will be performed at trough (immediately prior to dosing at the clinic). At study entry BP should be measured in both arms. The arm with the higher SBP reading should be used for the 4 measurements at screening visit and the same arm should be used at all subsequent visits.
Complete list of historical versions of study NCT01615198 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP) [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.
  • Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline, 4 weeks, 14 weeks ] [ Designated as safety issue: No ]
    Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement.
  • Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP) [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
    Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.
  • Change From Baseline in Mean Sitting Pulse Pressure [ Time Frame: Baseline, 4 weeks, 10 weeks, 14 weeks ] [ Designated as safety issue: No ]
    Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.
  • Change From Baseline in Daytime and Nighttime maSBP/maDBP [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.
  • Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative chnage from baseline indicates improvement.
  • Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative chnage from baseline indicates improvement.
  • Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: 4 weeks, 10 weeks, 14 weeks ] [ Designated as safety issue: No ]
    A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.
  • Number of Participants Achieving Successful Response in msSBP and msDBP [ Time Frame: 4 weeks,10 weeks, 14 weeks ] [ Designated as safety issue: No ]
    Blood pressure response in msSBP was defined as a mean sitting BP < 140 mmHg or a >=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or >=10 mmHg reduction from baseline.
  • Number of Participants With Adverse Events, Serious Adverse Events and Death [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
    Adverse event monitoring was conducted throughout the study.
  • Change from baseline in mean 24 hour ambulatory systolic blood pressure (maSBP) [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
    ABPM over a 24-hour period will be conducted at two time-points during the study in a subset of patients. Readings will be taken every 20 minutes over the 24 hour period in the non-dominant arm.
  • Change from baseline in mean sitting systolic blood pressure (msSBP) and mean sitting diastolic blood pressure (msDBP) [ Time Frame: Baseline to 4 weeks, 14 weeks ] [ Designated as safety issue: No ]
    Sitting BP measurements will be performed at trough (immediately prior to dosing at the clinic). At study entry BP should be measured in both arms. The arm with the higher SBP reading should be used for the 4 measurements at screening visit and the same arm should be used at all subsequent visits.
  • Change in baseline in mean 24 hour ambulatory diastolic blood pressure (maDBP) [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
    ABPM over a 24-hour period will be conducted at two time-points during the study in a subset of patients. Readings will be taken every 20 minutes over the 24 hour period in the non-dominant arm.
  • Change from baseline in mean sitting diastolic blood pressure (msDBP) [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
    Sitting BP measurements will be performed at trough (immediately prior to dosing at the clinic). At study entry BP should be measured in both arms. The arm with the higher SBP reading should be used for the 4 measurements at screening visit and the same arm should be used at all subsequent visits.
  • Office pulse pressure measurement [ Time Frame: 4 weeks, 10 weeks, 14 weeks ] [ Designated as safety issue: No ]
    Pulse rate will be taken with automated BP device after the 4th blood pressure measurement at each visit
  • Change from baseline in daytime and nighttime maSBP/maDBP [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    ABPM over a 24-hour period will be conducted at two time-points during the study in a subset of patients. Readings will be taken every 20 minutes over the 24 hour period in the non-dominant arm.
  • Change from baseline in maSBP and maDBP for daytime/nightime [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
    ABPM over a 24-hour period will be conducted at two time-points during the study in a subset of patients. Readings will be taken every 20 minutes over the 24 hour period in the non-dominant arm.
  • The precentage of patients achieving overall blood pressure control in mean sitting systolic blood pressure (msSBP) and mean sitting diastolic blood pressure (msDBP) [ Time Frame: 4 weeks, 10 weeks, 14 weeks ] [ Designated as safety issue: No ]
    A successful response in overall BP control rate defined as msSBP < 140 mmHg and msDBP <90 mmHg
  • Percentage of patients achieving successful response in diastolic blood pressure (msDBP) [ Time Frame: 4 weeks,10 weeks, 14 weeks ] [ Designated as safety issue: No ]
    A successful response in overall BP control rate defined as msSBP (<140 mmHg or a reduction ≥ 20 mmHg from baseline) and msDBP (< 90 mmHg or a reduction ≥ 10 mmHg from baseline).
  • Number of patients with adverse events, serius adverse events and death [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
A 14 Week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension

The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Essential Hypertension
  • Drug: Olmesartan
    10 mg, 20 mg, 40 mg capsules
  • Drug: Placebo
    Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule
  • Drug: LCZ696
    100 mg, 200 mg tablets
  • Experimental: LCZ696
    Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
    Interventions:
    • Drug: Placebo
    • Drug: LCZ696
  • Active Comparator: Olmesartan
    Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
    Interventions:
    • Drug: Olmesartan
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
588
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must give written informed consent before any assessment is performed
  • Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and < 180 mmHg
  • Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance

Exclusion criteria:

  • Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients with history of angioedema, drug-related or otherwise
  • Patients with history or evidence of a secondary form of hypertension
  • Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke
  • History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
  • Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).
  • Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication
  • Patients with previous or current diagnosis of heart failure (NYHA Class II-IV).
  • Patients with a clinically significant valvular heart disease at the time of screening
  • Women of child-bearing potential, who do not use adequate birth control methods Other protocol-defined inclusion/exclusion criteria may apply
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Hong Kong,   Japan,   Korea, Republic of,   Philippines,   Taiwan,   Thailand
 
NCT01615198
CLCZ696A2316
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP