SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00299832

Enrollment

Registered

2006-03-07

Start date

2006-04-30

Completion date

2007-05-31

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, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction

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 * Elevated Serum Creatinine

Exclusion criteria

* Patients suspected of malignant hypertension * Patients with a clinically significant allergy * Patients who have received other investigational drug Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Adverse events after 8 weeks	—

Secondary

Measure	Time frame
Change from baseline in mean sitting systolic blood pressure after 8 weeks	—
Change from baseline in mean sitting diastolic blood pressure after 8 weeks	—
Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks	—
Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks	—
Blood pressure <140/90 after 8 weeks	—

Countries

Japan

Outcome results

None listed

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