NCT01461499

Brief Summary

The purpose of this study is to compare the effects of a direct renin inhibitor (DRI), aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes under strict blood pressure control with angiotensin receptor blocker (ARB).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
237

participants targeted

Target at P75+ for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2011

Typical duration for phase_4 type-2-diabetes-mellitus

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, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

February 19, 2018

Completed
Last Updated

February 19, 2018

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

October 19, 2011

Results QC Date

November 11, 2016

Last Update Submit

August 15, 2017

Conditions

Type 2 Diabetes MellitusHypertension

Keywords

HypertensionAlbuminuriaDirect renin inhibitorAngiotensin receptor blockerType 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Reduction in Albuminuria

    Change in the urinary albumin to creatinine ratio (UACR) from the baseline

    baseline and 24 weeks

Secondary Outcomes (3)

  • Change in the Urinary Angiotensinogen Level

    baseline and 24 weeks

  • Change in the Plasma Renin Activity

    baseline and 24 weeks

  • Change in the Serum Insulin Level

    baseline and 24 weeks

Study Arms (2)

Direct renin inhibitor

ACTIVE COMPARATOR
Drug: Aliskiren

Angiotensin receptor blockers

ACTIVE COMPARATOR
Drug: any angiotensin receptor blockers

Interventions

AliskirenDRUG

The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.

Direct renin inhibitor
any angiotensin receptor blockersDRUG

The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.

Angiotensin receptor blockers

Eligibility Criteria

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

You may qualify if:

  • Segment: outpatients
  • Hypertension: taking an anti-hypertensive treatment or indicating mean sitting SBP/DBP more than130/80 mmHg
  • Type 2 diabetes: diagnosed by ADA criteria or under an anti-diabetic drug treatment
  • Microalbuminuria: 10 \< and \< 300 mg/gCr
  • Informed consent: patients who understand well about this study based on own voluntary will and can give a written consent

You may not qualify if:

  • Sever hypertension (over 180/110 mmHg), malignant hypertension and secondary hypertension
  • Type 1 diabetes
  • Patients whose investigator regards as difficult to comply with study protocol in reference to the package insert of aliskiren
  • Patients who have history of operation in gastrointestinal tract surgery, and anamnestic or concurrent gastrointestinal disorders, which may interfere with drug absorption
  • Serum potassium \> 5.6 mEq/L (hyperkalemia)
  • Urinary microalbumin \< 10 or \> 300 mg/gCr
  • Patients who participated in another clinical study within three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiga University of Medical Science

Ōtsu, Shiga, 520-2192, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionAlbuminuria

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Steering Committee: Takashi Uzu
Organization
Shiga University of Medical Science
takuzu@belle.shiga-med.ac.jp
81-77-548-2222

Study Officials

  • Hiroshi Maegawa, M.D.

    Shiga University of Medical Science

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 28, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

February 19, 2018

Results First Posted

February 19, 2018

Record last verified: 2017-08

Locations

JP(1)