SPP100 Dose Finding Study in Japan

Phase 2

Completed

• Conditions: Hypertension

• Registration Number: NCT00311012
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2006-03-31
• Study First Submitted QC: 2006-04-04
• Study First Posted: 2006-04-05
• Status Verified: 2006-06
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 445

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇯🇵 Tokyo, Japan