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

A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Parallel-Design, Four-Week Study to Investigate the Safety and Efficacy of the Oral Renin Inhibitor SPP635 Once Daily in Patients With Mild to Moderate Hypertension

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00376636

Enrollment

Registered

2006-09-15

Start date

2006-10-31

Completion date

2007-05-31

Last updated

2007-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

Detailed 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.

Interventions

DRUGSPP635 (drug)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* male or female patients with mild to moderate hypertension

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Lowering of systolic office blood pressure	four weeks
Lowering of diastolic office blood pressure	four weeks

Secondary

Measure	Time frame
Lowering of systolic and diastolic blood pressure (ABPM)	four weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026