Phase 2
N=454
Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01692301 ↗Enrolled (actual)
454
Serious AEs
6.4%
Results posted
May 2016
Primary outcome: Primary: Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks — -12.57; -8.90 mmHg — p=0.010
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LCZ696 (Drug); Olmesartan (Drug); LCZ696 matching placebo (Drug); Olmesartan matching placebo (Drug); amlodipine (Drug); hydrochlorothiazide (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks |
-12.57; -8.90 | 0.010 sig |
| SECONDARY Change From Baseline in Mean Central Pulse (CPP) Pressure |
-6.41; -3.96; -7.16; -6.65 | — |
| SECONDARY Change From Baseline in Mean Pulse Wave Velocity (PWV) |
-0.68; -0.57; -0.83; 0.77 | — |
| SECONDARY Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks |
-16.18; -14.70 | — |
| SECONDARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) |
-20.84; -14.57; -23.91; -21.45 | — |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) |
-7.86; -5.58; -8.92; -7.85 | — |
| SECONDARY Change From Baseline in Mean Sitting Pulse Pressure (msPP) |
-13.13; -8.86; -15.02; -13.58 | — |
| SECONDARY Change From Baseline in Mean Arterial Pressure (MAP) |
-12.19; -8.57; -13.92; -12.38 | — |
| SECONDARY Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP) |
-13.25; -9.14; -14.15; -14.32 | — |
| SECONDARY Change From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP) |
-7.44; -5.48; -8.85; -8.44 | — |
| SECONDARY Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP) |
-5.77; -3.69; -5.26; -5.91 | — |
Summary
The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).
Eligibility Criteria
Key Inclusion Criteria
- Male and female patients ≥ 60 years of age.
- Patients with essential hypertension, untreated or currently taking antihypertensive therapy.
- Untreated patients must have an office msSBP ≥150 mmHg and 60 mmHg at Visit 201. Pulse pressure is defined as msSBP- msDBP.
- Patients must have a difference in msSBP within +/-15 mmHg between Visit 201 (randomization) and the visit immediately prior to Visit 201.
Key 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, and drug-induced 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.
- History of atrial fibrillation or atrial flutter during the 3 months prior to Visit 1, or active atrial fibrillation or atrial flutter on the ECG at screening.
Data sourced from ClinicalTrials.gov (NCT01692301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.