A study to evaluate the effect of LCZ696 on artery stiffness in subjects with high blood pressure.

Phase 1

• Conditions: Hypertensive patients.; MedDRA version: 17.1Level: SOCClassification code 10047065Term: Vascular disordersSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 17.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-005720-15-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-24
• Last Update Posted: 27 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

•Subjects with essential hypertension, untreated or currently taking antihypertensive therapy:
•Untreated subjects must have mean seated (ms) SBP= 140 mmHg and < 180 mmHg at screening and baseline.
•Treated subjects must have a msSBP < 180 mmHg at screening and a mean seated SBP = 140 mmHg and < 180 mmHg at baseline after washout of antihypertensive drugs.
•Pulse rate between 45 and 100 bpm, inclusive at screening and baseline.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•WOCBP if not on highly effective contraception
•Malignant or severe hypertension (grade 3 of WHO classification; msDBP =110 mmHg and/or msSBP =180 mmHg) at screening or at baseline.
•History of angioedema, drug-related or otherwise.
•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 any percutaneous coronary intervention (PCI) during the 12 months prior to screening.
•History of peripheral artery disease requiring surgical or percutaneous interventions during the 12 months prior to screening.
•Type 1 diabetes mellitus.
•Type 2 diabetes mellitus not well controlled with oral anti-diabetic medication or treated with insulin.
•Previous or current diagnosis of heart failure (New York Heart Association Class II-IV).
•Clinically significant valvular heart disease at screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified