NCT00376636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_2 hypertension

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

October 30, 2007

Status Verified

September 1, 2006

First QC Date

September 14, 2006

Last Update Submit

October 29, 2007

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Lowering of systolic office blood pressure

    four weeks

  • Lowering of diastolic office blood pressure

    four weeks

Secondary Outcomes (1)

  • Lowering of systolic and diastolic blood pressure (ABPM)

    four weeks

Interventions

SPP635 (drug)DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female patients with mild to moderate hypertension

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IKP Bobenheim GmbH

Mannheim, 68167, Germany

Location

MeSH Terms

Conditions

Hypertension

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Sybille Baumann-Noss, MD

    IKP Bobenheim GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2006

First Posted

September 15, 2006

Study Start

October 1, 2006

Study Completion

May 1, 2007

Last Updated

October 30, 2007

Record last verified: 2006-09

Locations

DE(1)