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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
Hypertension Drug: SPP635 (drug) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Identifier: NCT00376636     History of Changes
Other Study ID Numbers: SPP635CRD04
Study First Received: September 14, 2006
Last Updated: October 29, 2007

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on June 23, 2017