CompletedPhase 2

A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension

Germany, Switzerland, United Kingdom115 participantsStarted 2013-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Ascending Aorta Distensibility at 52 Week

Timeframe: Baseline, 52 weeks

Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks

Timeframe: Baseline, 52 weeks

Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks

Timeframe: Baseline, 52 weeks

Trial details

NCT IDNCT01870739

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06

Results submitted2016-05-31

View on ClinicalTrials.gov More Hypertension trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in Ascending Aorta Distensibility at 52 Week

Timeframe: Baseline, 52 weeks

Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks

Timeframe: Baseline, 52 weeks

Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks

Timeframe: Baseline, 52 weeks