NCT00246584

Brief 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)

Trial Health

80
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ 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

Study Start

First participant enrolled

October 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
Last Updated

July 28, 2006

Status Verified

July 1, 2006

First QC Date

October 27, 2005

Last Update Submit

July 27, 2006

Conditions

Hypertension

Keywords

Hypertensionangiotensinreninaliskiren

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events, vital signs, abnormal laboratory changes,etc.

Secondary Outcomes (3)

  • 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

Interventions

SPP100DRUG

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as essential hypertension -

You may not qualify if:

  • Patients with secondary hypertension or suspected of having secondary hypertension.
  • Patients suspected of having malignant hypertension
  • Patients with any serious diseases or symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

Basel, Switzerland

Location

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 31, 2005

Study Start

October 1, 2004

Last Updated

July 28, 2006

Record last verified: 2006-07

Locations

CH(1)