Trials Sponsors Conditions Drugs Pricing

Conditions

Proteinuria Hypertension Type II Diabetes

Keywords

ENaCAmilorideHydrochlorothiazide(HCTZ)HypertensionType II DiabetesNatriuresisProteinuria

Outcome Measures

Primary Outcomes (1)

Blood Pressure
Change in clinic systolic BP. This BP measure will be the average of three serial BP measurements taken one minute apart after 5 minutes of sitting quietly.
one month

Secondary Outcomes (1)

Hypertension
one month

Study Arms (2)

Amiloride 10 mg, 20 mg, and diet

EXPERIMENTAL

Amiloride 10 mg for 14 days and diet. Then dose titrated up at day 14 to 20 mg, and diet.

Drug: Amiloride

HCTZ 12.5 mg, 25 mg and diet

ACTIVE COMPARATOR

HCTZ 12.5 mg for 14 days and diet. Then dose titrated up at day 14 to 25 mg, and diet

Drug: HCTZ

Interventions

AmilorideDrug

Amiloride 10 mg taken every day for two weeks, along with adherence to specified diet. On day 14 titrate dose up to Amiloride 20 mg, take every day for two weeks after completion of two week intake of Amiloride 10 mg, along with adherence to specified diet.

Also known as: Midamor

Amiloride 10 mg, 20 mg, and diet

HCTZDrug

HCTZ 12.5 mg taken every day for two weeks, along with adherence to specified diet. On day 14 titrate dose up to HCTZ 25 mg taken every day for two weeks after completion of two week intake of HCTZ 12.5 mg, along with adherence to specified diet

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 to 80 yrs at randomization
History of Type 2 Diabetes

Sponsors & Collaborators

Dialysis Clinic, Inc.
Industrycollaborator
University of Pittsburgh
Othercollaborator
University of New Mexico

Study Sites (1)

University of New Mexico Hospital; Clinical & Translational Science Center

Albuquerque, New Mexico, 87131, United States

Related Publications (1)

Passero CJ, Hughey RP, Kleyman TR. New role for plasmin in sodium homeostasis. Curr Opin Nephrol Hypertens. 2010 Jan;19(1):13-9. doi: 10.1097/MNH.0b013e3283330fb2.
PMID: 19864949BACKGROUND

MeSH Terms

Conditions

ProteinuriaHypertensionDiabetes Mellitus, Type 2

Interventions

AmilorideHydrochlorothiazide

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Mark L Unruh, MD MSc
University of New Mexico
PRINCIPAL INVESTIGATOR

Enrollment

9 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: HEALTH SERVICES RESEARCH
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 1, 2013

First Posted

March 5, 2013

Study Start

March 2013

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Epithelial Sodium Channel (ENaC) as a Novel Mechanism for Hypertension and Volume Expansion in Type 2 Diabetes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Amiloride 10 mg, 20 mg, and diet

HCTZ 12.5 mg, 25 mg and diet

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Amiloride 10 mg, 20 mg, and diet

HCTZ 12.5 mg, 25 mg and diet

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations