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

Condition(s) targeted: Hypertension

Intervention: SPP100 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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)

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

Study design: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Incidence of adverse events, vital signs, abnormal laboratory changes,etc.

Secondary outcome:

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

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: October 2004
Last updated: July 27, 2006