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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

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)

Condition or disease Intervention/treatment Phase
Hypertension Drug: SPP100 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Treatment, Multicenter, Open-Label Study With SPP100 in Patients With Essential Hypertension
Study Start Date : October 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Aliskiren




Primary Outcome Measures :
  1. Incidence of adverse events, vital signs, abnormal laboratory changes,etc.

Secondary Outcome Measures :
  1. Change from baseline in diastolic blood pressure after 52 weeks
  2. Change from baseline in systolic blood pressure after 52 weeks
  3. Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT00246584


Locations
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Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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ClinicalTrials.gov Identifier: NCT00246584    
Other Study ID Numbers: CSPP100A1202
First Posted: October 30, 2005    Key Record Dates
Last Update Posted: July 28, 2006
Last Verified: July 2006
Keywords provided by Novartis:
Hypertension
angiotensin
renin
aliskiren
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases