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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01870739
First received: June 3, 2013
Last updated: April 15, 2014
Last verified: April 2014

June 3, 2013
April 15, 2014
October 2013
July 2015   (final data collection date for primary outcome measure)
  • Change from baseline in ascending aorta distensibility at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Cardiovascular magnetic resonance imaging (MRI) scans will be obtained at baseline prior to randomization, at week 12 for the assessment of local aortic distensibility.
  • Change from baseline in proximal descending aorta distensibility at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Cardiovascular magnetic resonance imaging (MRI) scans will be obtained at baseline prior to randomization, at week 12 for the assessment of local aortic distensibility.
  • Change from baseline in distal descending aorta distensibility at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Cardiovascular magnetic resonance imaging (MRI) scans will be obtained at baseline prior to randomization, at week 12 for the assessment of local aortic distensibility.
Same as current
Complete list of historical versions of study NCT01870739 on ClinicalTrials.gov Archive Site
  • Change from baseline in local aortic strain at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Cardiovascular magnetic resonance imaging (MRI) scans will be obtained at baseline prior to randomization, at week 12 for the assessment of local aortic strain.
  • Change from baseline in regional aortic pulse wave velocity at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Cardiovascular magnetic resonance imaging (MRI) scans will be obtained at baseline prior to randomization, at week 12 for the assessment of regional aortic pulse wave velocity.
  • Change from baseline in Central blood pressure at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in augmentation pressure at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Augmentation pressure is the added pressure during systole due to wave reflection.
  • Change from baseline in augmentation index at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Augmentation index is the percentage of the central pulse pressure due to wave reflection.
  • Change from baseline in pulse wave velocity at 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Number of patients with reported adverse events, serious adverse events and death [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension
A Randomized, Double-blind, Active-controlled, Parallel Group, 52-week Study to Evaluate the Effect of LCZ696 Compared to Olmesartan on Regional Aortic Stiffness in Subjects With Essential Hypertension

This is 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • Drug: LCZ696
  • Drug: olmesartan
  • Other: placebo to LCZ696
    placebo
  • Other: placebo to olmesartan
    placebo
  • Experimental: LCZ696
    Patients will receiveLCZ696 once daily (q.d.) + placebo to olmesartan q.d.
    Interventions:
    • Drug: LCZ696
    • Other: placebo to olmesartan
  • Active Comparator: olmesartan
    Patients will receive olmesartan once daily (q.d.) + mg placebo to LCZ696 q.d.
    Interventions:
    • Drug: olmesartan
    • Other: placebo to LCZ696
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
July 2015
July 2015   (final data collection date for primary outcome measure)

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).

Other protocol defined inclusion and exclusion criteria may apply

Both
18 Years and older
No
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals
Germany,   Switzerland,   United Kingdom
 
NCT01870739
CLCZ696A2224, 2012-005720-15
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP