Phase 2
N=114
A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01870739 ↗Enrolled (actual)
114
Serious AEs
4.5%
Results posted
Sep 2016
Primary outcome: Primary: Change From Baseline in Ascending Aorta Distensibility at 52 Week — 0.269; 0.330 10^(-3) x mmHg^(-1) — p=0.7324
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sacubitril/valsartan (LCZ696) (Drug); olmesartan (Drug); placebo to sacubitril/valsartan (LCZ696) (Other); placebo to olmesartan (Other); Amlodipine (Optional) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ascending Aorta Distensibility at 52 Week |
0.269; 0.330 | 0.7324 |
| PRIMARY Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks |
0.510; 0.547 | 0.8614 |
| PRIMARY Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks |
0.417; 0.498 | 0.7946 |
| SECONDARY Change From Baseline in Local Aortic Strain at 52 Weeks |
-0.830; 0.453; -0.284; -0.066; -1.092; 0.225 | — |
| SECONDARY Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks |
-2.086; -1.085 | — |
| SECONDARY Change From Baseline in Central Blood Pressure at 52 Weeks |
-16.655; -13.625; -10.318; -10.432; -6.539; -3.041 | — |
| SECONDARY Change From Baseline in Augmentation Pressure at 52 Weeks |
-2.443; -1.437 | — |
| SECONDARY Change From Baseline in Augmentation Index at 52 Weeks |
-2.385; -1.515 | — |
| SECONDARY Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks |
-0.428; -0.434 | — |
| SECONDARY Number of Patients With Reported Adverse Events, Serious Adverse Events and Death |
13; 16; 21; 28; 31; 38 | — |
Summary
This was the first evaluation of the effects of LCZ696 on local and regional measures of aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure. The results of this exploratory study will help to understand the mechanism of action of LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with cardiovascular diseases.
Eligibility Criteria
Key Inclusion Criteria
- Subjects with essential hypertension, untreated or currently taking antihypertensive therapy
Key exclusion Criteria
- women of child bearing potential (WOCBP) if not on highly effective contraception
- Malignant or severe hypertension (grade 3 of WHO classification)
- History or evidence of a secondary form of hypertension
- Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
- Previous or current diagnosis of heart failure (New York Heart Association Class II-IV).
Data sourced from ClinicalTrials.gov (NCT01870739). 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.