NCT00219076

Brief Summary

To evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in combination with amlodipine 5 mg in patients with essential hypertension not adequately responsive to amlodipine 5 mg.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
504

participants targeted

Target at P50-P75 for phase_3 hypertension

Geographic Reach
2 countries

2 active sites

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

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

September 12, 2005

Last Update Submit

May 16, 2017

Conditions

Hypertension

Keywords

Hypertension, aliskiren, blood pressure, amlodipine

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mean sitting diastolic blood pressure after 6 weeks

Secondary Outcomes (5)

  • Change from baseline in mean sitting systolic blood pressure after 6 weeks

  • Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 6 weeks

  • Achieve mean sitting blood pressure target of < 140/90 mmHg after 6 weeks

  • Change from baseline in standing diastolic blood pressure after 6 weeks

  • Change from baseline in standing systolic blood pressure after 6 weeks

Interventions

aliskirenDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with essential hypertension

You may not qualify if:

  • Severe hypertension
  • History or evidence of a secondary form of hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Location

Unknown Facility

Investigative Centers, Germany

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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

February 1, 2005

Primary Completion

October 1, 2005

Last Updated

May 18, 2017

Record last verified: 2017-05

Locations

DE(1)US(1)