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Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential 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: NCT01237873
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Ali/Amlo 150/2.5 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Open-label, 52 Week, Extension to an 8-week, Double Blind, Multicenter, 6-arm, Placebo-controlled, Parallel Group Study to Evaluate the Long Term Safety of SPA100 (Aliskiren/Amlodipine)
Study Start Date : January 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ali/Amlo
Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
Drug: Ali/Amlo 150/2.5 mg
Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg




Primary Outcome Measures :
  1. Long-term safety of the fixed-dose combination of aliskiren/ amlodipine [ Time Frame: 52 weeks ]
    Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.


Secondary Outcome Measures :
  1. Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine. [ Time Frame: 52 weeks ]
    this endpoint will measure the change from baseline for mean sitting diastolic blood pressure, mean sitting systolic blood pressure, supine diastolic blood pressure, supine systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure.

  2. The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients that complete CSPA100A1301 study
  • Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled

Exclusion Criteria:

  • Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study
  • Presence of major protocol violation in CSPA100A1301 study

Other protocol-defined inclusion/exclusion criteria may apply


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): NCT01237873


Locations
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Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 231-0023
Novartis Investigative Site
Koshigaya city, Saitama, Japan, 343-0826
Novartis Investigative Site
Edogawa-ku, Tokyo, Japan, 133-0061
Novartis Investigative Site
Katsushika-ku, Tokyo, Japan, 124-0024
Novartis Investigative Site
Kiyose, Tokyo, Japan, 204-0021
Novartis Investigative Site
Kunitachi, Tokyo, Japan, 186-0001
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 105-7390
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 108-0075
Novartis Investigative Site
Ota-ku, Tokyo, Japan, 143-0023
Novartis Investigative Site
Shibuya-ku, Tokyo, Japan, 150-0002
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan, 141-0032
Novartis Investigative Site
Tachikawa, Tokyo, Japan, 190-0013
Novartis Investigative Site
Toshima-ku, Tokyo, Japan, 171-0021
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01237873    
Other Study ID Numbers: CSPA100A1302
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Aliskiren
Amlodipine
Essential hypertension
Long term
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents