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

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01237873

Enrollment

150

Registered

2010-11-10

Start date

2011-01-31

Completion date

2012-02-29

Last updated

2017-02-23

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

Conditions

Essential Hypertension

Keywords

Aliskiren, Amlodipine, Essential hypertension, Long term

Brief summary

The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.

Interventions

DRUGAli/Amlo 150/2.5 mg

Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients that complete CSPA100A1301 study * Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled

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/

Design outcomes

Primary

Measure	Time frame	Description
Long-term safety of the fixed-dose combination of aliskiren/ amlodipine	52 weeks	Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.

Secondary

Measure	Time frame	Description
Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.	52 weeks	this endpoint will measure the change from baseline for mean sitting diastolic blood pressure, mean sitting systolic blood pressure, supine diastolic blood pressure, supine systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure.
The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study	52 weeks	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026