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NCT00246584 Clinical Trial

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

Hypertension Clinical Trial

Official title:
Long-Term Treatment, Multicenter, Open-Label Study With SPP100 in Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00246584
Other study ID # CSPP100A1202
Secondary ID
Status Completed
Phase Phase 2
First received October 27, 2005
Last updated July 27, 2006
Start date October 2004

Study information
Verified date July 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 safety and efficacy of long term treatment of SPP100 in patients with essential hypertension. (Trial is not recruiting in the US)

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Diagnosed as essential hypertension -

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SPP100

Locations
Country Name City State
Switzerland Novartis Pharmaceuticals Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events, vital signs, abnormal laboratory changes,etc.
Secondary Change from baseline in diastolic blood pressure after 52 weeks
Secondary Change from baseline in systolic blood pressure after 52 weeks
Secondary Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks
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