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

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.
 
ClinicalTrials.gov Identifier: NCT00376636
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : October 30, 2007
Sponsor:
Information provided by:
Speedel Pharma Ltd.

Tracking Information
First Submitted Date  ICMJE September 14, 2006
First Posted Date  ICMJE September 15, 2006
Last Update Posted Date October 30, 2007
Study Start Date  ICMJE October 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2007)
  • Lowering of systolic office blood pressure [ Time Frame: four weeks ]
  • Lowering of diastolic office blood pressure [ Time Frame: four weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2006)
  • Lowering of systolic office blood pressure
  • Lowering of diastolic office blood pressure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2007)
Lowering of systolic and diastolic blood pressure (ABPM) [ Time Frame: four weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase IIa Safety and Efficacy Study of SPP635 in Mild to Moderate Hypertension
Official Title  ICMJE 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
Brief Summary This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood pressure in patients with mild to moderate hypertension.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: SPP635 (drug)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2006)
35
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • male or female patients with mild to moderate hypertension

Exclusion Criteria:

  • female patients of child-bearing potential or breast-feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00376636
Other Study ID Numbers  ICMJE SPP635CRD04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Speedel Pharma Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sybille Baumann-Noss, MD IKP Bobenheim GmbH
PRS Account Speedel Pharma Ltd.
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP