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ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling

NCT01176032 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2014-07-24

Study results available
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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 patients.

Conditions

Interventions

DRUG

Aliskiren

Aliskiren 300 mg film coated tablets

DRUG

Losartan

Losartan 100 mg tablets

DRUG

Amlodipine

Amlodipine 5mg was given to patients who did not achieve the required blood pressure (\<140/90 mmHg) after 8 weeks (visit 3)of treatment at the maximum doses of study medication in addition to the study medication in order to reach the required BP. at visit 4 (week 18) the dose of amlodipine was increased to 10mg if the required level (\<140/90 mmHg) was still not achieved.

DRUG

Hydrochlorothiazide (HCTZ)

HCTZ 12.5mg was prescribed at visit 5 (week 26) if the required values (\<140/90 mmHg) had not been reached.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01176032 on ClinicalTrials.gov