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SPP100 Dose Finding Study in Japan

NCT ID: NCT00311012

Last Updated: 2011-11-08

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

PHASE2

Total Enrollment

445 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-03-31

Brief Summary

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This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.

Detailed Description

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Conditions

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Hypertension

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

1. Mild to moderate essential hypertension
2. Age: ≥20 years old and \<80 years old (at time informed consent obtained)
3. Sex: N/A
4. Admission status: Outpatient

Exclusion Criteria

1. Pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant
2. Patients having a mean sitting diastolic blood pressure of ≥110 mmHg and/or a mean sitting systolic blood pressure of ≥180 mmHg at either Visit 2 or 3
3. Patients with secondary hypertension as a complication or patients suspected of having secondary hypertension(due to aortic coarctation, primary aldosteronism, coarctation of renal artery, renal hypertension
4. Patients suspected of having malignant hypertension
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals, Japan

Role: PRINCIPAL_INVESTIGATOR

Novartis Pharmaceuticals, Japan

Locations

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Novartis Pharmaceuticals

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CSPP100A1201

Identifier Type: -

Identifier Source: org_study_id