At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 556 enrolled

Drug / intervention

Aliskiren +2 moredrug

Likely dose

Aliskiren 150 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/NCT00402103

NCT00402103Phase 3Completed

Compare CT.gov

A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg / Amlodipine 10 mg in Patients With Essential Hypertension

Novartis·interventional·Posted Nov 22, 2006·Updated Mar 10, 2011

In Brief

A Phase 3 clinical trial evaluating Aliskiren, Amlodipine, and 1 other intervention for Hypertension. Completed, enrolled 556 participants across 8 sites in 8 countries.

Detailed Summary

To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHypertension

CountriesBelgium, Denmark, Finland, Germany, Iceland, India, Switzerland, United States

Collaborators--

Timeline

Phase 3CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 2006

First PostedNov 2006

Primary CompletionApr 2008

TodayJul 2026

First PostedNov 22, 2006

Enrollment StartNov 1, 2006

Primary CompletionApr 1, 2008

TodayJul 2, 2026

Enrollment to primary: 1.4 yearsPosted 19.6 years ago

Interventions

Aliskirendrug

All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration

Amlodipinedrug

All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration

Hydrochlorothiazidedrug

Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.