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

This study has been completed.
Information provided by:
Speedel Pharma Ltd. Identifier:
First received: September 14, 2006
Last updated: October 29, 2007
Last verified: September 2006

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
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:

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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00376636

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

No publications provided 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:
Vascular Diseases
Cardiovascular Diseases processed this record on April 17, 2014