A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)

Phase 2

Completed

• Conditions: Hypertension

• Registration Number: NCT00246584
• Lead Sponsor: Novartis

Brief Summary

This study will evaluate the safety and efficacy of long term treatment of SPP100 in patients with essential hypertension. (Trial is not recruiting in the US)

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-10-27
• Study First Submitted QC: 2005-10-28
• Study First Posted: 2005-10-30
• Status Verified: 2006-07
• Last Update Submitted: 2006-07-27
• Last Update Posted: 2006-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Diagnosed as essential hypertension -

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Exclusion Criteria

• Patients with secondary hypertension or suspected of having secondary hypertension.
• Patients suspected of having malignant hypertension
• Patients with any serious diseases or symptoms

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events, vital signs, abnormal laboratory changes,etc.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in diastolic blood pressure after 52 weeks
Change from baseline in systolic blood pressure after 52 weeks
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland