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

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 essentialhypertension

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221310

Enrollment

936

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 with essential hypertension (msDBP more than 95 mmHg and below 110 mmHg and msSBP more than 140 mmHg) - Outpatients

Exclusion criteria

Exclusion criteria: - Severe hypertension (msDBP more than 110 mmHg and/or msSBP more than 180 mmHg) - History of allergy or hypersensitivity to renin inhibitors, calcium channel blockers - History or evidence of a secondary hypertension Other protocol-defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
msDBP Reduction in msDBP from baseline to end of study	—

Secondary

Measure	Time frame
msSBP Reduction in msSBP from baseline to end of study blood pressure control Achieving blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) at endpoint successful response Achieving a successful response (msDBP < 90 mmHg or a reduction more than 10 mmHg from baseline) Safety The assessment of safety will be based primarily on the frequency of adverse events (AEs), lab abnormalities and serious adverse events (SAEs).	—

Measure

Time frame

msSBP Reduction in msSBP from baseline to end of study blood pressure control Achieving blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) at endpoint successful response Achieving a successful response (msDBP < 90 mmHg or a reduction more than 10 mmHg from baseline) Safety The assessment of safety will be based primarily on the frequency of adverse events (AEs), lab abnormalities and serious adverse events (SAEs).

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Outcome results

None listed

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