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

Tracking Information

First Received Date ^ICMJE

February 26, 2007

Last Updated Date

July 17, 2008

Start Date ^ICMJE

January 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00441064 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Aliskiren

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

122

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00441064

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CSPP100AUS02

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Novartis

Information Provided By

Novartis

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP