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

This study has been completed.
Sponsor:
Information provided by:
Speedel Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT00376636
First received: September 14, 2006
Last updated: October 29, 2007
Last verified: September 2006
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00376636     History of Changes
Other Study ID Numbers: SPP635CRD04
Study First Received: September 14, 2006
Last Updated: October 29, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013