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NCT00441064 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Novartis.

Completed
Registry status
Phase 4
Development phase
132
Enrollment target

NCT00441064: Completed Phase 4 study, sponsored by Novartis.

NCT00441064 is a Phase 4 study that has completed, run by Novartis. The registered enrollment target is 132 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00441064, a Phase 4 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 4
Development phase
132 participants
Enrollment target

Study 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.

Primary Outcome

The primary objective of the study was to assess mean 24 hour ambulatory systolic blood pressure (MASBP) in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. \[At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MASBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).\]

Interventions

  • DRUG Aliskiren

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2007-01
Est. Completion 2007-11
Phase Phase 4
Novartis

265 total trials

What the finished NCT00441064 record still lists

NCT00441064 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 1 intervention - of which Aliskiren is the first listed.

NCT00441064 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00441064 about?

NCT00441064 is a clinical study titled "Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren". 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.

What is the current status of trial NCT00441064?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 132 participants. The study started on 2007-01. Estimated completion is 2007-11.

What interventions are being tested in trial NCT00441064?

The interventions under investigation include: Aliskiren (DRUG).

Who is sponsoring clinical trial NCT00441064?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00441064's enrollment target sits among peer trials

132 610th of 2000 higher than 1,382 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00441064, the US trial registry maintained by the National Library of Medicine. NCT00441064 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.