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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00376636
First Posted: September 15, 2006
Last Update Posted: October 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Speedel Pharma Ltd.
  Purpose
This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood pressure in patients with mild to moderate hypertension.

Condition Intervention Phase
Hypertension Drug: SPP635 (drug) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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

Further study details as provided by Speedel Pharma Ltd.:

Primary Outcome Measures:
  • Lowering of systolic office blood pressure [ Time Frame: four weeks ]
  • Lowering of diastolic office blood pressure [ Time Frame: four weeks ]

Secondary Outcome Measures:
  • Lowering of systolic and diastolic blood pressure (ABPM) [ Time Frame: four weeks ]

Enrollment: 35
Study Start Date: October 2006
Study Completion Date: May 2007
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female patients with mild to moderate hypertension

Exclusion Criteria:

  • female patients of child-bearing potential or breast-feeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376636


Locations
Germany
IKP Bobenheim GmbH
Mannheim, Germany, 68167
Sponsors and Collaborators
Speedel Pharma Ltd.
Investigators
Principal Investigator: Sybille Baumann-Noss, MD IKP Bobenheim GmbH
  More Information

ClinicalTrials.gov Identifier: NCT00376636     History of Changes
Other Study ID Numbers: SPP635CRD04
First Submitted: September 14, 2006
First Posted: September 15, 2006
Last Update Posted: October 30, 2007
Last Verified: September 2006

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases