Phase 2
N=72
Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
Salt-sensitive Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01681576 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Cumulative Sodium Excretion (Natriuresis) at Day 1 — 61.26; 37.13; 188.87; 138.92 mmol
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Valsartan (Drug); LCZ696 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Sodium Excretion (Natriuresis) at Day 1 |
61.26; 37.13; 188.87; 138.92 | — |
| SECONDARY Cumulative Sodium Excretion (Natriuresis) at Day 28 |
39.30; 44.57; 144.71; 153.82 | — |
| SECONDARY Urine Volume (Diuresis) Over Time |
855.1; 806.2; 2752.8; 2756.2; 1215.9; 923.0 | — |
| SECONDARY Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time |
140.20; 137.85; 127.01; 132.07; 80.43; 80.57 | — |
| SECONDARY Mean Sitting Pulse Pressure (PP) Over Time |
63.91; 64.92; 71.91; 69.61; 65.21; 63.63 | — |
Summary
This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.
Eligibility Criteria
Key Inclusion Criteria
- Written informed consent must be obtained before any study assessment is performed.
- Males and females of non-childbearing potential and of legal age (at least 18 years or older as defined by local law).
- Asian patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy with up to two drugs.
Key Exclusion Criteria
- Women of child-bearing potential.
- History of angioedema, drug-related or otherwise
- History of hypersensitivity to LCZ696, valsartan, or drugs of similar chemical classes.
- Severe hypertension (grade 3 of WHO classification; msDBP ≥100 mmHg and/or msSBP ≥ 180 mmHg) at screening or at the end of the washout period.
- 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.
- History of myocardial infarction, coronary bypass surgery or percutaneous coronary intervention (PCI) during 12 month prior to screening.
- Current or history of hypertensive retinopathy.
- Previous or current diagnosis of heart failure (NYHA Class II-IV).
- Clinically significant valvular heart disease at screening.
Other protocol defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01681576). 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.