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OpenTrials
Completed

NCT Number: NCT00219063

A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal.

To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.

Completed

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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, 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 inclusion exclusion criteria also apply.

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. Change from baseline in diastolic blood pressure after 26 weeks

Secondary outcomes

  1. Change from baseline in systolic blood pressure after 26 weeks

  2. Change from baseline in diastolic blood pressure after 6 weeks and 12 weeks

  3. Change from baseline in systolic blood pressure after 6 weeks and 12 weeks

  4. Blood pressure control target of < 140/90 mmHg after 6, 12, and 26 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 26 Week, Double-blind, Randomized, Multicenter, Parallel Group, Active-controlled Study Comparing Aliskiren to Ramipril With Optional Addition of Hydrochlorothiazide, Followed by a 4 Week Double-blind, Randomized, Placebo-controlled Withdrawal in Patients With Essential Hypertension

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
May 17, 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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