ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling (ALLMARK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01176032
First received: August 2, 2010
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of LV remodeling associated with LV hypertrophy (LVH) in hypertensive patients.


Condition Intervention Phase
Hypertension
Left Ventricle Hypertrophy
Drug: Aliskiren
Drug: Losartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The "ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling (ALLMARK)" Study

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in C-terminal propeptide of procollagen type I (PICP) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Measure: Plasma levels (ELISA)


Secondary Outcome Measures:
  • Change from baseline in other LV remodeling related biomarkers [cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); aldosterone (Aldo)] [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Measure: Plasma levels (ELISA)

  • Change in LV mass index and function Measure: Echocardiography [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Change in blood pressure (systolic and diastolic) Measure: Sphygmomanometer [ Time Frame: weeks 12, 20, 28 & 36 ] [ Designated as safety issue: No ]
  • Safety and tolerability Measure: Adverse event reports [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Change in creatinine, potassium, urinary albumin to creatinine ratio Measure: Usual laboratory assessment [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: June 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren
Aliskiren 300mg with the addition of amlodipine or hydrochlorothiazide if needed
Drug: Aliskiren
Aliskiren 300 mg
Active Comparator: Lostaran
Losartan 100 mg with the addition of amlodipine or hydrochlorothiazide if needed.
Drug: Losartan
Losartan 100 mg

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with hypertension
  • Confirmed concentric left ventricular hypertrophy:
  • LVMI > 49.2 g/m2.7 for men and >46.7 g/m2.7 for women
  • Relative wall thickness > 0.42

Exclusion Criteria:

  • Sever or secondary HTN
  • LV ejection fraction of <40%
  • Patient with compelling indication to ACEIs or ARBs or BB
  • History of myocardial infarction, coronary artery bypass surgery, PTC intervention, TIA or stroke within 6 months of study entry
  • History of collagenopathies, osteopathy
  • eGFR <30 ml/min/1,73 m2, serum potassium ≥5,2 mEq/L
  • Morbid obesity (BMI ≥ 42 kg/m2
  • Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176032

Locations
Spain
Novartis Investigative Site
Sanlúcar de Barrameda, Andalucia, Spain, 11540
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41009
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site
Utrera, Andalucia, Spain, 41710
Novartis Investigative Site
Burgos, Castilla y Leon, Spain, 09005
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08036
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08025
Novartis Investigative Site
Girona, Cataluña, Spain, 17007
Novartis Investigative Site
L'Hospitalet de Llobregat, Cataluña, Spain, 08907
Novartis Investigative Site
Santa Coloma de Gramanet, Cataluña, Spain
Novartis Investigative Site
Alicante, Comunidad Valenciana, Spain, 03004
Novartis Investigative Site
Torrevieja (Alicante), Comunidad Valenciana, Spain, 03186
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46014
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain, 15706
Novartis Investigative Site
Galdakano, Pais Vasco, Spain, 48960
Novartis Investigative Site
Bilbao, País Vasco, Spain, 48013
Novartis Investigative Site
Vitoria, País Vasco, Spain
Novartis Investigative Site
Barcelona, Spain, 08006
Novartis Investigative Site
Madrid, Spain, 28035
Novartis Investigative Site
Madrid, Spain, 28040
Novartis Investigative Site
Madrid, Spain, 28041
Novartis Investigative Site
Madrid, Spain, 28009
Novartis Investigative Site
Madrid, Spain, 28046
Novartis Investigative Site
Santander, Spain, 39008
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01176032     History of Changes
Other Study ID Numbers: CSPP100AES02, 2009-016735-36
Study First Received: August 2, 2010
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration
Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
Aliskiren
hypertension
concentric LVH
LV remodeling
LVMI
biomarkers
PICP
CT-1
MMP-1
TIMP-1
AnxA5
Aldosterone
Essential hypertension with concentric left ventricle hypertrophy

Additional relevant MeSH terms:
Hypertension
Hypertrophy
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014