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Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Ali/Amlo 150/2.5 mg
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Aliskiren, Amlodipine, Essential hypertension, Long term

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ali/Amlo

Arm Description

Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg

Outcomes

Primary Outcome Measures

Long-term safety of the fixed-dose combination of aliskiren/ amlodipine
Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.

Secondary Outcome Measures

Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.
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.
The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study

Full Information

First Posted
October 29, 2010
Last Updated
February 21, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01237873
Brief Title
Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
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 Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Aliskiren, Amlodipine, Essential hypertension, Long term

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ali/Amlo
Arm Type
Experimental
Arm Description
Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
Intervention Type
Drug
Intervention Name(s)
Ali/Amlo 150/2.5 mg
Intervention Description
Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
Primary Outcome Measure Information:
Title
Long-term safety of the fixed-dose combination of aliskiren/ amlodipine
Description
Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.
Description
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.
Time Frame
52 weeks
Title
The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
231-0023
Country
Japan
Facility Name
Novartis Investigative Site
City
Koshigaya city
State/Province
Saitama
ZIP/Postal Code
343-0826
Country
Japan
Facility Name
Novartis Investigative Site
City
Edogawa-ku
State/Province
Tokyo
ZIP/Postal Code
133-0061
Country
Japan
Facility Name
Novartis Investigative Site
City
Katsushika-ku
State/Province
Tokyo
ZIP/Postal Code
124-0024
Country
Japan
Facility Name
Novartis Investigative Site
City
Kiyose
State/Province
Tokyo
ZIP/Postal Code
204-0021
Country
Japan
Facility Name
Novartis Investigative Site
City
Kunitachi
State/Province
Tokyo
ZIP/Postal Code
186-0001
Country
Japan
Facility Name
Novartis Investigative Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-7390
Country
Japan
Facility Name
Novartis Investigative Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0075
Country
Japan
Facility Name
Novartis Investigative Site
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-0023
Country
Japan
Facility Name
Novartis Investigative Site
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-0002
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-0032
Country
Japan
Facility Name
Novartis Investigative Site
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0013
Country
Japan
Facility Name
Novartis Investigative Site
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
171-0021
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

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