Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT01876368
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 376
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LCZ696 200 mg LCZ696 Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. LCZ696 200 mg Placebo of LCZ696 Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. Olmesartan 20 mg Olmesartan Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. Olmesartan 20 mg Placebo of Olmesartan Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP) 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
Name Time Method Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP) 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) 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) 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 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 8 weeks Successful overall blood pressure control is defined as both msSBP/msDBP \<140/90 mmHg
Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control 8 weeks Successful mean sitting diastolic blood pressure control is defined as msDBP \<90 mmHg
Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response 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 8 weeks Number of patients with total adverse events, serious adverse events and death were reported.
Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control 8 weeks Successful mean sitting systolic blood pressure control is defined as msSBP \<140 mmHg
Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response baseline, 8 weeks Successful mean sitting systolic blood pressure response is defined as msSBP \<140 mmHg or a reduction ≥ 20 mmHg from baseline.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇪🇸Madrid, Spain