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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 )

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: LCZ696 Drug: Olmesartan Drug: Placebo of LCZ696 Drug: Placebo of Olmesartan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Drug: Olmesartan
Drug: Placebo of Olmesartan



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876368


  Show 51 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01876368     History of Changes
Other Study ID Numbers: CLCZ696A2318
2013-001783-36 ( EudraCT Number )
First Posted: June 12, 2013    Key Record Dates
Results First Posted: December 7, 2015
Last Update Posted: December 7, 2015
Last Verified: November 2015
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
hypertension,
LCZ696,
olmesartan
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Olmesartan Medoxomil
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action