CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,342 enrolled
Drug / intervention
Aliskiren/Amlodipine 150/2.5 mg +7 moredrug
Likely dose
Aliskiren/Amlodipine 150/2.5 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/NCT01237223
NCT01237223Phase 3Completed
CompareCT.gov

An 8-week Double-blind, Multicenter, Randomized, 6-arm, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in Patients With Essential Hypertension

Novartis·interventional·Posted Nov 9, 2010·Updated Jun 13, 2012

In Brief

A Phase 3 clinical trial evaluating Aliskiren/Amlodipine 150/2.5 mg, Aliskiren/amlodipine 150/5 mg, and 6 other interventions for Essential Hypertension. Completed, enrolled 1,342 participants across 11 sites.

Detailed Summary

The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with essential hypertension (mean sitting diastolic blood pressure \[msDBP\] ≥ 95 mmHg and \< 110 mmHg and mean sitting systolic blood pressure \[msSBP\] ≥ 140 mmHg ). This study was conducted to support registration of the fixed-dose combination of aliskiren and amlodipine for the treatment of hypertension in Japan.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Hypertension
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 9, 2010
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.6 years ago

Interventions

Aliskiren/Amlodipine 150/2.5 mgdrug

Aliskiren/amlodipine 150/2.5 mg tablet

Aliskiren/amlodipine 150/5 mgdrug

Aliskiren/amlodipine 150/5 mg tablet

Aliskiren 150 mgdrug

Aliskiren 150 mg tablet

Amlodipine 2.5 mgdrug

Amlodipine 2.5 mg capsule

Placebo of Aliskirendrug

Aliskiren placebo tablet

Placebo of Amlodipinedrug

Amlodipine placebo capsule

Placebo of Aliskiren/amlodipine 150/2.5 mgdrug

Aliskiren/amlodipine 150/2.5 mg placebo tablet

Placebo of Aliskiren/amlodipine 150/5 mgdrug

Aliskiren/amlodipine 150/5 mg placebo tablet