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OpenTrials
Completed

NCT Number: NCT00299832

SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction

Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction

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
  • Elevated Serum Creatinine

Exclusion criteria

  • Patients suspected of malignant hypertension
  • Patients with a clinically significant allergy
  • Patients who have received other investigational drug Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. Adverse events after 8 weeks

Secondary outcomes

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

  2. Change from baseline in mean sitting diastolic blood pressure after 8 weeks

  3. Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks

  4. Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks

  5. Blood pressure <140/90 after 8 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
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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