Long term safety of SPA100 (fixed-dose combination of aliskiren/amlodipine) in patients with essential hypertension

A open-label, 52 week, extension to an 8-week, double blind, multicenter, 6-arm, placebo-controlled, parallel group study to evaluate the long term safety of SPA100 (Aliskiren/Amlodipine)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221308

Enrollment

150

Registered

2010-11-15

Start date

2010-11-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential hypertension

Interventions

investigational material(s) Generic name etc : SPA100 INN of investigational material : Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational material : Once

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients that complete CSPA100A1301 study - Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled

Exclusion criteria

Exclusion criteria: - Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study - Presence of major protocol violation in CSPA100A1301 study Other protocol-defined inclusion/exclusion criteria may apply.

Design outcomes

Secondary

Measure	Time frame
Blood pressure lowering efficacy This endpoint will measure the change from baseline for mean sitting diastolic blood pressure(msDBP), mean sitting systolic blood pressure(msSBP). Blood pressure control Achieving blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) at endpoint	—

Primary

Measure	Time frame
Safety The assessment of safety will be based primarily on the frequency of adverse events (AEs), lab abnormalities and serious adverse events (SAEs).	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026