Study of the Efficacy and Safety of LCZ696 Alone and in Combination With Amlodipine in Patients With Hypertension
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: LCZ696 (Drug); Amlodipine (Drug); LCZ696 and amlodipine combination (Drug); Placebo (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Summary
To evaluate the blood pressure lowering effect and safety of LCZ696 when given alone and in
combination with amlodipine in patients with essential hypertension.
Clinical Details
Official title: An 8-week Randomized, Double-blind, Placebo-controlled Factorial Study to Evaluate the Efficacy and Safety of LCZ696 Alone and in Combination With Amlodipine in Patients With Essential Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change from baseline in mean sitting systolic blood pressure (msSBP) of LCZ696 monotherapy compared to placeboChange from baseline in mean sitting systolic blood pressure (msSBP) of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone.
Secondary outcome: Change from baseline in mean sitting Diastolic Blood Pressure (msDBP) of LCZ696 monotherapy compared to placeboChange from baseline in mean sitting Diastolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone Change from baseline in pulse pressure Change from baseline in mean 24-hour ambulatory Systolic Blood Pressure of LCZ696 monotherapy compared to placebo Change from baseline in mean 24-hour ambulatory Diastolic Blood Pressure of LCZ696 monotherapy compared to placebo Change from baseline in mean daytime ( > 6am and ≤ 10 pm) ambulatory Systolic Blood Pressure of LCZ696 monotherapy compared to placebo Change from baseline in mean daytime ( > 6am and ≤ 10 pm) ambulatory Diastolic Blood Pressure of LCZ696 monotherapy compared to placebo Change from baseline in mean nighttime (> 10 pm and ≤ 6 am) ambulatory Systolic Blood Pressure of LCZ696 monotherapy compared to placebo Change from baseline in mean nighttime (> 10 pm and ≤ 6 am) ambulatory Diastolic Blood Pressure of LCZ696 monotherapy compared to placebo Change from baseline in trough to peak ratio of mean 24-hour ambulatory Systolic Blood Pressure of LCZ696 monotherapy compared to placebo Change from baseline in trough to peak ratio of mean 24-hour ambulatory Diastolic Blood Pressure of LCZ696 monotherapy compared to placebo Change from baseline in mean 24-hour ambulatory Systolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone Change from baseline in mean 24-hour ambulatory Diastolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone Change from baseline in mean daytime ( > 6am and ≤ 10 pm) ambulatory Systolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone Change from baseline in mean daytime ( > 6am and ≤ 10 pm) ambulatory Diastolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone Change from baseline in mean nighttime (> 10 pm and ≤ 6 am) ambulatory Systolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone Change from baseline in mean nighttime (> 10 pm and ≤ 6 am) ambulatory Diastolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone Percentage of patients achieving msSBP <140 mmHg and msDBP <90 mmHg Percentage of patients achieving msSBP <140 mmHg or a reduction ≥20 mmHg from baseline Percentage of patients achieving msDBP <90 mmHg or a reduction ≥10 mmHg from baseline Number of patients reporting adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female outpatients
2. Patients with mild-to-moderate hypertension, untreated or currently taking
antihypertensive therapy
3. Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1)
must have an msSBP ≥150 mmHg and <180 mmHg at the randomization visit and msSBP ≥140
mmHg <180 mmHg at the preceding visit.
4. Untreated patients (newly diagnosed with essential hypertension or having a history
of hypertension but have not been taking any antihypertensive drugs for at least 4
weeks prior to Visit 1) must have an msSBP ≥150 mmHg and <180 mmHg at both the
randomization visit and the preceding visit.
5. Patients must have an absolute difference of ≤15 mmHg in msSBP between the
randomization visit and the preceding visit.
6. Ability to communicate and comply with all study requirements and demonstrate good
medication compliance (≥ 80% compliance rate) during the treatment run-in period.
Exclusion Criteria:
1. Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
2. History of angioedema, drug-related or otherwise
3. 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,
and drug-induced hypertension
4. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any
history of stroke
5. History of myocardial infarction, coronary bypass surgery or any percutaneous
coronary intervention (PCI) during the 12 months prior to Visit 1
6. Pregnant or lactating women
7. Women of child-bearing potential not using highly effective methods of contraception
Other protocol defined inclusion/exclusion criteria may apply
Locations and Contacts
Additional Information
Starting date: April 2014
Last updated: August 4, 2014
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