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NCT00402103 · ClinicalTrials.gov registry record · Phase 3

An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure

A Phase 3 study, sponsored by Novartis.

Completed
Registry status
Phase 3
Development phase
556
Enrollment target

NCT00402103: Completed Phase 3 study, sponsored by Novartis.

NCT00402103 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 556 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00402103, a Phase 3 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 3
Development phase
556 participants
Enrollment target

Study Summary

To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg).

Interventions

  • DRUG Amlodipine
  • DRUG Aliskiren
  • DRUG Hydrochlorothiazide

Trial Details

FieldValue
Enrollment Target 556 participants
Start Date 2006-11
Est. Completion 2008-04
Phase Phase 3
Novartis

265 total trials

What the finished NCT00402103 record still lists

NCT00402103 is an interventional study that assigns participants to a tested intervention. The registered 556 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).

The record links to 0 conditions, and to 3 interventions - of which Amlodipine is the first listed.

NCT00402103 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00402103 about?

NCT00402103 is a clinical study titled "An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure". To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg).

What is the current status of trial NCT00402103?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 556 participants. The study started on 2006-11. Estimated completion is 2008-04.

What interventions are being tested in trial NCT00402103?

The interventions under investigation include: Amlodipine (DRUG), Aliskiren (DRUG), Hydrochlorothiazide (DRUG).

Who is sponsoring clinical trial NCT00402103?

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

How this trial's enrollment target compares

Where NCT00402103's enrollment target sits among peer trials

556 675th of 2000 higher than 1,325 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00402103, the US trial registry maintained by the National Library of Medicine. NCT00402103 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.