Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
- Registration Number
- NCT01681576
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description LCZ696 followed by Valsartan LCZ696 Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks Valsartan followed by LCZ696 LCZ696 Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks Valsartan followed by LCZ696 Valsartan Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks LCZ696 followed by Valsartan Valsartan Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
- Primary Outcome Measures
Name Time Method Cumulative Sodium Excretion (Natriuresis) at Day 1 0-6 and 0-24 hours on Day 1 Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 1
- Secondary Outcome Measures
Name Time Method Cumulative Sodium Excretion (Natriuresis) at Day 28 0-6 and 0-24 hours on Day 28 Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 28
Mean Sitting Pulse Pressure (PP) Over Time Day-1, Day 14 and Day 28 Sitting mean pulse pressure rate was calculated between ambulatory SBP and DBP measurements
Urine Volume (Diuresis) Over Time Day -1, Day 1 & Day 28 Urine will be collected and volume measured in fractions of 0 to 6 hours and 0 to 24 hours Day-1, Day 1 and Day 28
Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time Day-1, Day 14 and Day 28 Seated Office BP (systolic blood pressure (SBP) and diastolic blood pressure (DBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇳Taipei, Taiwan