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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01237873
First received: October 29, 2010
Last updated: March 22, 2012
Last verified: March 2012
History of Changes

October 29, 2010
March 22, 2012
January 2011
February 2012   (final data collection date for primary outcome measure)
Long-term safety of the fixed-dose combination of aliskiren/ amlodipine [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.
Same as current
Complete list of historical versions of study NCT01237873 on ClinicalTrials.gov Archive Site
  • Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
 
 
 
Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
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)

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.
 
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Essential Hypertension
Drug: Ali/Amlo 150/2.5 mg
Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
Experimental: Ali/Amlo
Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
Intervention: Drug: Ali/Amlo 150/2.5 mg
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01237873
CSPA100A1302
 
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
 
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2012

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