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

NCT ID: NCT00344110

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

768 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-04-30

Brief Summary

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

Detailed Description

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Conditions

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Hypertension

Keywords

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Hypertension, aliskiren, blood pressure, renin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Aliskiren

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals, Japan

Role: STUDY_CHAIR

Novartis Pharmaceuticals, Japan

Locations

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Novartis Pharmaceuticals

Japan, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CSPP100A1301

Identifier Type: -

Identifier Source: org_study_id