Status:
COMPLETED
ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Left Ventricle Hypertrophy
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in hypertensive pati...
Detailed Description
Blood pressure was measured 10 weeks after starting treatment (visit 3). All patients who did not achieve the required blood pressure (\<140/90 mmHg) after 8 weeks of treatment at the maximum doses of...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01176032
Start Date
June 1 2010
End Date
April 1 2013
Last Update
July 24 2014
Active Locations (25)
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1
Novartis Investigative Site
Sanlúcar de Barrameda, Andalusia, Spain, 11540
2
Novartis Investigative Site
Seville, Andalusia, Spain, 41009
3
Novartis Investigative Site
Seville, Andalusia, Spain, 41013
4
Novartis Investigative Site
Utrera, Andalusia, Spain, 41710