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

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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: SPP635 (drug) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
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
Study Start Date : October 2006
Actual Study Completion Date : May 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Lowering of systolic office blood pressure [ Time Frame: four weeks ]
  2. Lowering of diastolic office blood pressure [ Time Frame: four weeks ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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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
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Germany
IKP Bobenheim GmbH
Mannheim, Germany, 68167
Sponsors and Collaborators
Speedel Pharma Ltd.
Investigators
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Principal Investigator: Sybille Baumann-Noss, MD IKP Bobenheim GmbH
More Information
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ClinicalTrials.gov Identifier: NCT00376636    
Other Study ID Numbers: SPP635CRD04
First Posted: September 15, 2006    Key Record Dates
Last Update Posted: October 30, 2007
Last Verified: September 2006
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases