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Trial record 16 of 135 for:    OLMESARTAN

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

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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 )

Tracking Information
First Submitted Date  ICMJE June 9, 2013
First Posted Date  ICMJE June 12, 2013
Results First Submitted Date  ICMJE July 29, 2015
Results First Posted Date  ICMJE December 7, 2015
Last Update Posted Date December 7, 2015
Study Start Date  ICMJE September 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2013)
Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP) [ Time Frame: baseline, 8 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01876368 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2015)
  • Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP) [ Time Frame: baseline, 8 weeks ]
    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.
  • Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: baseline, 8 weeks ]
    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
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: baseline, 8 weeks ]
    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
  • Change From Baseline in Office Pulse Pressure [ Time Frame: baseline, 8 weeks ]
    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.
  • Number of Patients Achieving Successful Overall Blood Pressure Control [ Time Frame: 8 weeks ]
    Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg
  • Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control [ Time Frame: 8 weeks ]
    Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg
  • Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control [ Time Frame: 8 weeks ]
    Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg
  • Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response [ Time Frame: baseline, 8 weeks ]
    Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.
  • Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response [ Time Frame: baseline, 8 weeks ]
    Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction ≥10 mmHg from baseline.
  • Number of Patients With Total Adverse Events, Serious Adverse Events and Death [ Time Frame: 8 weeks ]
    Number of patients with total adverse events, serious adverse events and death were reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2013)
  • Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP) [ Time Frame: baseline, 8 weeks ]
    Twenty-four hour mean ambulatory blood pressure measurements 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.
  • Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: baseline, 8 weeks ]
    Sitting blood pressure (BP) will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements.
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: baseline, 8 weeks ]
    Sitting BP will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements.
  • Change From Baseline in Office Pulse Pressure [ Time Frame: baseline, 8 weeks ]
    Mean sitting pulse pressure will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.
  • Percentage of patients achieving successful overall blood pressure control [ Time Frame: 8 weeks ]
    Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg
  • Number of Patients With Total Adverse Events, Serious Adverse Events and Death [ Time Frame: 8 weeks ]
  • Percentage of patients achieving successful mean sitting systolic blood pressure (msSBP) control [ Time Frame: 8 weeks ]
    Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg
  • Percentage of patients achieving successful mean sitting diastolic blood pressure (msDBP) control [ Time Frame: 8 weeks ]
    Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg
  • Percentage of patients achieving successful mean sitting systolic blood pressure (msSBP) response [ Time Frame: baseline, 8 weeks ]
    Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or ≥ 20 mmHg
  • Percentage of patients achieving successful mean sitting diastolic blood pressure (msDBP) response [ Time Frame: baseline, 8 weeks ]
    Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or ≥10 mmHg
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan
Official Title  ICMJE A Randomized 8-week Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of LCZ696 200 mg in Comparison With Olmesartan 20 mg in Essential Hypertensive Patients Not Responsive to Olmesartan
Brief Summary This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: LCZ696
  • Drug: Olmesartan
  • Drug: Placebo of LCZ696
  • Drug: Placebo of Olmesartan
Study Arms  ICMJE
  • Experimental: LCZ696 200 mg
    Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
    Interventions:
    • Drug: LCZ696
    • Drug: Placebo of LCZ696
  • Active Comparator: Olmesartan 20 mg
    Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
    Interventions:
    • Drug: Olmesartan
    • Drug: Placebo of Olmesartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2015)
376
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2013)
526
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with mild to moderate hypertension, untreated or currently taking antihypertensive therapy
  • treated patients (using antihypertensive drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and < 180 mmHg after washout epoch and after 4 weeks run-in epoch
  • untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and < 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and < 180 mmHg after 4 weeks run-in epoch
  • patients must successfully complete ABPM and pass technical requirements to be qualified for randomization

Exclusion Criteria:

  • Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
  • History of angioedema, drug-related or otherwise
  • History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease (PKD), drug-induced hypertension
  • Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Guatemala,   Philippines,   Puerto Rico,   Russian Federation,   Spain,   United States
Removed Location Countries Venezuela
 
Administrative Information
NCT Number  ICMJE NCT01876368
Other Study ID Numbers  ICMJE CLCZ696A2318
2013-001783-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date November 2015

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