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Completed

NCT Number: NCT01237873

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

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Yokohama, Kanagawa, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ali/Amlo 150/2.5 mg

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 10, 2010
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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