CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 965 enrolled
Drug / intervention
Amlodipine 5 mg +3 moredrug
Likely dose
Amlodipine 5 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/NCT00699192
NCT00699192Phase 3Completed
CompareCT.gov

A Multicenter, Double-blind, Randomized, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 mg as Compared to Amlodipine/Valsartan 5/40 mg or to Amlodipine 5 mg Once Daily in Elderly Patients With Essential Hypertension Not Adequately Controlled After Four Weeks on Amlodipine 5 mg Once Daily

Novartis Pharmaceuticals·interventional·Posted Jun 17, 2008·Updated Jun 6, 2011

In Brief

A Phase 3 clinical trial evaluating Amlodipine 5 mg, Valsartan 80 mg, and 2 other interventions for Hypertension. Completed, enrolled 965 participants across 18 sites in 10 countries.

Detailed Summary

To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesCzechia, Finland, France, Germany, Hungary, Italy, Poland, Slovakia, Spain, Sweden
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 17, 2008
Enrollment StartMay 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.0 years ago

Interventions

Amlodipine 5 mgdrug

1 capsule amlodipine 5 mg orally once daily

Valsartan 80 mgdrug

1 capsule valsartan 80 mg orally once daily

Valsartan 40 mgdrug

1 capsule valsartan 40 mg orally once daily

Placebodrug

1 capsule placebo to match valsartan orally once daily