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OpenTrials
Completed

NCT Number: NCT00219128

A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren 150mg, 300mg, and 600mg to Placebo in Patients With High Blood Pressure.

Evaluate the blood pressure lowering effect of aliskiren 150mg, 300mg and 600mg compared to placebo in patients with essential hypertension

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with essential hypertension
  • Patients who are eligible and able to participate in the study

Exclusion criteria

  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. Change from baseline in diastolic blood pressure after 8 weeks

Secondary outcomes

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

  2. Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 weeks and 8 weeks

  3. Blood pressure <140/90 mmHg after 4 weeks and 8 weeks

  4. Evaluate potential return of hypertension at 4 days and 2 weeks after 8 weeks

  5. Evaluate high and low level drug effect using 24 hour blood pressure monitoring

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

An Eight-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing Aliskiren 150 mg, 300 mg, and 600 mg to Placebo in Patients With Essential Hypertension

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Nov 8, 2011

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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