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A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)

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: NCT00246584
Recruitment Status : Completed
First Posted : October 30, 2005
Last Update Posted : July 28, 2006
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE October 27, 2005
First Posted Date  ICMJE October 30, 2005
Last Update Posted Date July 28, 2006
Study Start Date  ICMJE October 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2006)
Incidence of adverse events, vital signs, abnormal laboratory changes,etc.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2006)
  • Change from baseline in diastolic blood pressure after 52 weeks
  • Change from baseline in systolic blood pressure after 52 weeks
  • Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 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 A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)
Official Title  ICMJE Long-Term Treatment, Multicenter, Open-Label Study With SPP100 in Patients With Essential Hypertension
Brief Summary This study will evaluate the safety and efficacy of long term treatment of SPP100 in patients with essential hypertension. (Trial is not recruiting in the US)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: SPP100
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
Enrollment  ICMJE
 (submitted: June 1, 2006)
300
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed as essential hypertension -

Exclusion Criteria:

  • Patients with secondary hypertension or suspected of having secondary hypertension.
  • Patients suspected of having malignant hypertension
  • Patients with any serious diseases or symptoms
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 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 Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00246584
Other Study ID Numbers  ICMJE CSPP100A1202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date July 2006

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