Skip to main content
OpenTrials
Completed

NCT Number: NCT00219167

A Clinical Study to Assess Efficacy and Safety of Aliskiren in the Elderly With High Blood Pressure

After a wash-out (1 to 2 weeks), and 2 to 4 week single-blind placebo run-in period, eligible patients will be randomized to receive lisinopril 10 mg, aliskiren 75 mg, 150 mg or 300 mg for a period of 8 weeks

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with at least 65 years-old
  • Patients with essential hypertension Exclusion Criteria
  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks

Secondary outcomes

  1. Change from baseline in average 24 hour diastolic ambulatory blood pressure after 8 weeks

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

  3. Change from baseline in daytime diastolic ambulatory blood pressure after 8 weeks

  4. Change from baseline in daytime systolic ambulatory blood pressure after 8 weeks

  5. Blood pressure control target of < 140/90 mmHg after 8 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

An 8-week, Randomized, Double-blind, Parallel-group, Multicenter Study Assessing the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Patients With at Least 65 Years of Age With Essential Hypertension, Using 24-hour ABPM, With Lisinopril 10 mg as a Reference

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.