CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 74 enrolled
Drug / intervention
Aliskiren +3 moredrug
Likely dose
Aliskiren 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01176032
NCT01176032Phase 4Completed
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The "ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling (ALLMARK)" Study

Novartis Pharmaceuticals·interventional·Posted Aug 5, 2010·Updated Jul 24, 2014

In Brief

A Phase 4 clinical trial evaluating Aliskiren, Losartan, and 2 other interventions for Hypertension and Left Ventricle Hypertrophy. Completed, enrolled 74 participants across 25 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Left Ventricle Hypertrophy
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 5, 2010
Enrollment StartJun 1, 2010
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.9 years ago

Interventions

Aliskirendrug

Aliskiren 300 mg film coated tablets

Losartandrug

Losartan 100 mg tablets

Amlodipinedrug

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.

Hydrochlorothiazide (HCTZ)drug

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