NCT00151827

Brief Summary

This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
393

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2003

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

August 1, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

October 14, 2010

Status Verified

October 1, 2010

Enrollment Period

1.9 years

First QC Date

September 8, 2005

Last Update Submit

October 13, 2010

Conditions

Essential HypertensionRenal Impairment

Outcome Measures

Primary Outcomes (1)

  • Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment

    Baseline to 12 weeks

Secondary Outcomes (7)

  • Change in mean sitting diastolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;

    Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks

  • Change in mean sitting systolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;

    Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks

  • Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment;

    Baseline to 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks

  • Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment;

    Baseline to 12 and 52 weeks

  • Changes in serum creatinine after 12 and 52 weeks of treatment

    Baseline to 12 and 52 weeks

  • +2 more secondary outcomes

Study Arms (2)

Olmesartan medoxomil

EXPERIMENTAL

Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.

Drug: Olmesartan medoxomilDrug: Furosemide oral tablets

Losartan

EXPERIMENTAL

Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo.

Drug: LosartanDrug: Furosemide oral tablets

Interventions

Olmesartan medoxomilDRUG

Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.

Olmesartan medoxomil
LosartanDRUG

Medications are taken once daily before breakfast with water.

Losartan
Furosemide oral tabletsDRUG

If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator

LosartanOlmesartan medoxomil

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mean sitting BP prior to randomization of 140-180/90-109 mmHg;
  • Renal impairment prior to randomization of mild (50 ≤ CLcr ≥ 80 mL/min) to moderate (30 ≤ CLcr ≥50 mL/min) severity

You may not qualify if:

  • Malignant hypertension or sitting BP greater than 180/109 mmHg;
  • Severe heart failure, severe renal disease;
  • Recent history of myocardial infarction, stroke or transient ischemic attack;
  • History, clinical or current evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial;
  • Hypersensitivity or contraindications to ARBs or ACE inhibitors or any cross allergy;
  • Treatment with dis-allowed medication;
  • Pregnant or breastfeeding females or females of childbearing potential without adequate contraception;
  • History of drug and/or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Darmstadt, Germany

Location

MeSH Terms

Conditions

Essential HypertensionRenal Insufficiency

Interventions

Olmesartan MedoxomilLosartanFurosemide

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSulfanilamidesSulfonamidesAmidesAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • P. U. Witte, MD, PhD

    IMFORM GmbH, Darmstadt, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

August 1, 2003

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

October 14, 2010

Record last verified: 2010-10

Locations

DE(1)