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Phase IIa Safety and Efficacy Study of SPP635 in Mild to Moderate Hypertension

NCT ID: NCT00376636

Last Updated: 2007-10-30

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

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-05-31

Brief Summary

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This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood pressure in patients with mild to moderate hypertension.

Detailed Description

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Renin-Angiotensin system blockade is a well established target for treatment of high blood pressure. Blocking the system at the initial step, however, is a rather new concept that could only be implemented very recently through the availability of novel, oral, renin inhibitors. This study investigates the safety and efficacy of a novel oral renin inhibitor, SPP635.

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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SPP635 (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male or female patients with mild to moderate hypertension

Exclusion Criteria

* female patients of child-bearing potential or breast-feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Speedel Pharma Ltd.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Sybille Baumann-Noss, MD

Role: PRINCIPAL_INVESTIGATOR

IKP Bobenheim GmbH

Locations

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IKP Bobenheim GmbH

Mannheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SPP635CRD04

Identifier Type: -

Identifier Source: org_study_id