Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00441064

Purpose

This study will compare the effects of high and low level sodium (salt) diets on blood pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren	Phase IV

MedlinePlus related topics: Dietary Sodium High Blood Pressure

Drug Information available for: Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label, Blinded Endpoint, Multi-Center, Cross-Over Study to Evaluate the Effect of High and Low Sodium Diets on Reduction in Mean 24-Hour Ambulatory Blood Pressure in Systolic Hypertensive Patients Treated With Aliskiren (300 mg)

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in mean 24-hour ambulatory systolic blood pressure on aliskiren 300mg for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet

Secondary Outcome Measures:

Change in mean 24-hour ambulatory diastolic blood pressure on aliskiren 300 mg for 4 weeks on a high sodium diet versus 4 wks on a low sodium diet.
Responder rate defined as a drop in systolic blood pressure (SBP) of 20 mmHg or a mean 24-hour ambulatory SBP of < 130 mmHg from baseline on aliskiren 300 mg for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet.

Estimated Enrollment:	122
Study Start Date:	January 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female outpatients 18-60 years old
Subjects with hypertension

Exclusion Criteria:

History of heart attack or stroke within the preceding six months.
Unstable angina pectoris.
Type 1 or Type 2 diabetes mellitus or abnormal hemoglobin (Hb)A1c body mass index (BMI) > 30
Subjects taking more than 2 antihypertensive medications.
Use of other investigational drugs at the time of enrollment within 30 days
Flomax® (tamsulosin hydrochloride) and other alpha blockers.
Antiarrhythmic drugs, including digoxin.
History of cancer within the past 5 years with the exception of localized basal cell carcinoma of the skin
Pregnant or nursing (lactating) women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441064

Locations

United States, California
Novartis US
Orangevale, California, United States
United States, Minnesota
Novartis US
Brooklyn Center, Minnesota, United States
United States, Montana
Novartis US
Missoula, Montana, United States
Novartis US
Butte, Montana, United States
United States, Nebraska
Novartis US
Lincoln, Nebraska, United States
United States, New York
Novartis US
Johnson City, New York, United States
United States, North Carolina
Novartis US
Shelby, North Carolina, United States
Novartis US
Asheboro, North Carolina, United States
United States, Ohio
Novartis US
Cincinnati, Ohio, United States
Novartis US
Kettering, Ohio, United States
United States, Pennsylvania
Novartis US
Downington, Pennsylvania, United States
Novartis US
Pittsburg, Pennsylvania, United States
Novartis US
Erie, Pennsylvania, United States
United States, Texas
Novartis US
Dallas, Texas, United States
Novartis US
Kingsport, Texas, United States
United States, Utah
Novartis US
Salt Lake City, Utah, United States
Novartis US
Bountiful, Utah, United States
United States, Washington
Novartis US
Port Orchard, Washington, United States
United States, Wisconsin
Novartis US
Madison, Wisconsin, United States

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPP100AUS02
Study First Received:	February 26, 2007
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00441064
Health Authority:	United States: Institutional Review Board

Keywords provided by Novartis:

High blood pressure, hypertension, aliskiren, low sodium diet

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009