Phase IIa Safety and Efficacy Study of SPP635 in Mild to Moderate Hypertension

Speedel Pharma

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: SPP635 (drug)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00376636

SPP635CRD04

Details and patient eligibility

About

This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood pressure in patients with mild to moderate hypertension.

Full description

Renin-Angiotensin system blockade is a well established target for treatment of high blood pressure. Blocking the system at the initial step, however, is a rather new concept that could only be implemented very recently through the availability of novel, oral, renin inhibitors. This study investigates the safety and efficacy of a novel oral renin inhibitor, SPP635.

Enrollment: 35 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female patients with mild to moderate hypertension

Exclusion criteria

• female patients of child-bearing potential or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind