Status:

COMPLETED

SPP100 Dose Finding Study in Japan

Lead Sponsor:

Novartis

Conditions:

Hypertension

Eligibility:

All Genders

20-80 years

Phase:

PHASE2

Brief Summary

This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.

Eligibility Criteria

Inclusion

  • Mild to moderate essential hypertension
  • Age: ≥20 years old and \<80 years old (at time informed consent obtained)
  • Sex: N/A
  • Admission status: Outpatient

Exclusion

  • Pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant
  • Patients having a mean sitting diastolic blood pressure of ≥110 mmHg and/or a mean sitting systolic blood pressure of ≥180 mmHg at either Visit 2 or 3
  • Patients with secondary hypertension as a complication or patients suspected of having secondary hypertension(due to aortic coarctation, primary aldosteronism, coarctation of renal artery, renal hypertension
  • Patients suspected of having malignant hypertension

Key Trial Info

Start Date :

August 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2005

Estimated Enrollment :

445 Patients enrolled

Trial Details

Trial ID

NCT00311012

Start Date

August 1 2004

End Date

March 1 2005

Last Update

November 8 2011

Active Locations (1)

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Novartis Pharmaceuticals

Tokyo, Japan