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Completed

NCT Number: NCT00376636

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IKP Bobenheim GmbH

Mannheim, 68167, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male or female patients with mild to moderate hypertension

Exclusion criteria

  • female patients of child-bearing potential or breast-feeding

Treatment and study plan

SPP635 (drug)

Drug

Primary outcomes

  1. Lowering of systolic office blood pressure

    Time frame: four weeks

  2. Lowering of diastolic office blood pressure

    Time frame: four weeks

Secondary outcomes

  1. Lowering of systolic and diastolic blood pressure (ABPM)

    Time frame: four weeks

Sponsors and collaborators

Lead sponsor

Speedel Pharma Ltd.

Industry

Registry information

Official study title

A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Parallel-Design, Four-Week Study to Investigate the Safety and Efficacy of the Oral Renin Inhibitor SPP635 Once Daily in Patients With Mild to Moderate Hypertension

Important dates

Study start
2006
Study completion
2007
First posted
Sep 15, 2006
Registry last updated
Oct 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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