SPP100 Dose Finding Study in Japan

This study has been completed.

First Received: March 31, 2006 Last Updated: June 1, 2006 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00311012

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren	Phase II

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Aliskiren

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Dose-Finding Study of SPP100 in Essential Hypertension

Further study details as provided by Novartis:

Primary Outcome Measures:

Secondary Outcome Measures:

Change from baseline in mean sitting systolic blood pressure after 8 weeks
Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline after 8 weeks
Evaluate response to various doses by assessing the difference in mean sitting diastolic blood pressure after 8 weeks

Estimated Enrollment:	440
Study Start Date:	August 2004
Estimated Study Completion Date:	March 2005

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311012

Locations

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Pharmaceuticals, Japan

More Information

No publications provided

Study ID Numbers:	CSPP100A1201
Study First Received:	March 31, 2006
Last Updated:	June 1, 2006
ClinicalTrials.gov Identifier:	NCT00311012 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Hypertension, Aliskiren

Study placed in the following topic categories:

Signs and Symptoms
Essential Hypertension
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009