NCT00344110

Brief Summary

Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension

Trial Health

87
On Track

Trial Health Score

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

Enrollment
768

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3 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

June 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

June 22, 2006

Last Update Submit

November 16, 2016

Conditions

Hypertension

Keywords

Hypertension, aliskiren, blood pressure, renin

Outcome Measures

Primary Outcomes (1)

  • Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan

Secondary Outcomes (5)

  • Mean sitting systolic pressure (msSBP) lowering from baseline to the study end to placebo and losartan

  • Successful response; msDBP <90mmHg and/or a reduction of msDBP ≥ 10mmHg

  • Control rate; msDBP <90mmHg and msSBP<140mmHg

  • The pharmacokinetics / pharmacodynamics

  • Safety and tolerability

Interventions

AliskirenDRUG

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 20 - 75 years old
  • Gender: Male or female
  • Status: Outpatients
  • Mild to moderate essential hypertension

You may not qualify if:

  • Pregnant women, lactating mothers, women suspected of being pregnant, or women who wish to be pregnant
  • Patients with msSBP \>==180 mmHg and/or msDBP \>=110 mmHg at Visit 1, 2 or 3
  • Patients with or suspected of having secondary hypertension (due to aortic coarctation, primary aldosteronism, etc.)
  • Patients suspected of having malignant hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

Japan, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals, Japan

    Novartis Pharmaceuticals, Japan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2006

First Posted

June 26, 2006

Study Start

June 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

JP(1)