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

Essential Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237873
• Other study ID #: CSPA100A1302
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2010
• Last updated: February 21, 2017
• Start date: January 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Ali/Amlo 150/2.5 mg
Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Edogawa-ku	Tokyo
Japan	Novartis Investigative Site	Katsushika-ku	Tokyo
Japan	Novartis Investigative Site	Kiyose	Tokyo
Japan	Novartis Investigative Site	Koshigaya city	Saitama
Japan	Novartis Investigative Site	Kunitachi	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Ota-ku	Tokyo
Japan	Novartis Investigative Site	Shibuya-ku	Tokyo
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Tachikawa	Tokyo
Japan	Novartis Investigative Site	Toshima-ku	Tokyo
Japan	Novartis Investigative Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety of the fixed-dose combination of aliskiren/ amlodipine	Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.	52 weeks
Secondary	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.	52 weeks
Secondary	The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study		52 weeks

External Links

•   Results for CSPA100A1302 from the Novartis Clinical Trials website