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

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ClinicalTrials.gov Identifier: NCT00219167
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : April 2005
Primary Completion Date : February 2006
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Aliskiren
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

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): NCT00219167


Locations
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Additional Information:
Publications:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219167     History of Changes
Other Study ID Numbers: CSPP100A2324
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis:
hypertension
aliskiren
age

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases