SPP100 Dose Finding Study in Japan

Hypertension Clinical Trial

Official title:

Dose-finding Study of SPP100 in Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311012
• Other study ID #: CSPP100A1201
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2006
• Last updated: November 7, 2011
• Start date: August 2004
• Est. completion date: March 2005

Study information

• Verified date: June 2006
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Mild to moderate essential hypertension

2. Age: =20 years old and <80 years old (at time informed consent obtained)

3. Sex: N/A

4. Admission status: Outpatient

Exclusion Criteria:

1. Pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant

2. 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

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

4. Patients suspected of having malignant hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Aliskiren

Locations

Country	Name	City	State
Japan	Novartis Pharmaceuticals	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Secondary	Change from baseline in mean sitting systolic blood pressure after 8 weeks
Secondary	Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline after 8 weeks
Secondary	Evaluate response to various doses by assessing the difference in mean sitting diastolic blood pressure after 8 weeks