SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

A Multi-center, Open-label Study Assessing the Safety and Efficacy of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00299806

Enrollment

Registered

2006-03-07

Start date

2006-04-30

Completion date

2006-11-30

Last updated

2016-11-18

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

Conditions

Hypertension

Keywords

Hypertension, aliskiren, blood pressure, rennin

Brief summary

Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension

Interventions

DRUGAliskiren

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age: 20 - 80 years old * Gender: Male or female * Status: Outpatients * severe hypertension

Exclusion criteria

* Patients with a clinically significant allergy * Patients who have received other investigational drug * Alcoholic patients Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events after 8 weeks	—

Secondary

Measure	Time frame
Change from baseline in mean sitting systolic and diastolic blood pressure after 8 weeks	—
Average sitting systolic blood pressure/mean sitting diastolic blood is < 160/100 mmHg or blood pressure reduction from baseline is > 20/10 mmHg after 8 weeks	—
Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks.	—

Countries

Japan

Outcome results

None listed

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