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

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ClinicalTrials.gov Identifier: NCT00219063
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: aliskiren Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 844 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : February 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Change from baseline in diastolic blood pressure after 26 weeks

Secondary Outcome Measures :
  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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219063


Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications of Results:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219063     History of Changes
Other Study ID Numbers: CSPP100A2306
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Novartis:
Hypertension, aliskiren, blood pressure, Ramipril, hydrochlorothiazide

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Ramipril
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors