Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension

A Randomized, Double-blind, Placebo and Active-controlled, Multicenter, Parallel-group Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg to Evaluate Efficacy, Safety and Pharmacokinetics in Patients With Mild to Moderate Essential Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00344110

Enrollment

768

Registered

2006-06-26

Start date

2006-06-30

Completion date

2007-04-30

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, renin

Brief summary

Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension

Interventions

DRUGAliskiren

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Inclusion criteria

* Age: 20 - 75 years old * Gender: Male or female * Status: Outpatients * Mild to moderate essential hypertension

Exclusion criteria

* Pregnant women, lactating mothers, women suspected of being pregnant, or women who wish to be pregnant * Patients with msSBP \>==180 mmHg and/or msDBP \>=110 mmHg at Visit 1, 2 or 3 * Patients with or suspected of having secondary hypertension (due to aortic coarctation, primary aldosteronism, etc.) * Patients suspected of having malignant hypertension Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan	—

Secondary

Measure	Time frame
Mean sitting systolic pressure (msSBP) lowering from baseline to the study end to placebo and losartan	—
Successful response; msDBP <90mmHg and/or a reduction of msDBP ≥ 10mmHg	—
Control rate; msDBP <90mmHg and msSBP<140mmHg	—
The pharmacokinetics / pharmacodynamics	—
Safety and tolerability	—

Countries

Japan

Outcome results

None listed

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