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OpenTrials
Completed

NCT Number: NCT00299806

SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 20 - 80 years old
  • Gender: Male or female
  • Status: Outpatients
  • severe hypertension

Exclusion criteria

  • Patients with a clinically significant allergy
  • Patients who have received other investigational drug
  • Alcoholic patients

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. Incidence of adverse events after 8 weeks

Secondary outcomes

  1. Change from baseline in mean sitting systolic and diastolic blood pressure after 8 weeks

  2. Average sitting systolic blood pressure/mean sitting diastolic blood is < 160/100 mmHg or blood pressure reduction from baseline is > 20/10 mmHg after 8 weeks

  3. Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Multi-center, Open-label Study Assessing the Safety and Efficacy of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Mar 7, 2006
Registry last updated
Nov 18, 2016

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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