NCT00882440

Brief Summary

The purpose of this study was to compare the antihypertensive efficacy of different doses of losartan compared to placebo and enalapril, in patients with supine diastolic blood pressure of 100-115 mmHg.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
576

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Dec 1990

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

December 1, 1990

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 1991

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1992

Completed
17.3 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2009

Completed
2 months until next milestone

Results Posted

Study results publicly available

June 10, 2009

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

8 months

First QC Date

April 14, 2009

Results QC Date

April 17, 2009

Last Update Submit

August 17, 2015

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8

    24 hours post dose at Baseline and Week 8

Secondary Outcomes (2)

  • Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8

    24 hours post dose at Week 8

  • Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8

    6 hours post dose at Baseline and 8 weeks

Study Arms (7)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

EXPERIMENTAL

Losartan 10 mg

Drug: losartan potassium

3

EXPERIMENTAL

Losartan 25 mg

Drug: losartan potassium

4

EXPERIMENTAL

Losartan 50 mg

Drug: losartan potassium

5

EXPERIMENTAL

Losartan 100 mg

Drug: losartan potassium

6

EXPERIMENTAL

Losartan 150 mg

Drug: losartan potassium

7

ACTIVE COMPARATOR

Enalapril 20 mg

Drug: Enalapril

Interventions

losartan potassiumDRUG

losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks

Also known as: MK0954, Cozaar
23456
PlaceboDRUG

Placebo capsule to losartan

1
EnalaprilDRUG

Enalapril 20 mg oral tablet taken once daily for 8 weeks

7

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has been diagnosed with mild to moderate hypertension, with supine diastolic blood pressure of 100 to 115 mmHg
  • Patient has no active medical problems other than essential hypertension that might affect blood pressure
  • Patient has received no drug therapy that might affect blood pressure

You may not qualify if:

  • Prior exposure to losartan
  • History of stroke
  • History of myocardial infarction
  • Atrial flutter or atrial fibrillation
  • History of congestive Heart failure
  • Known Sensitivity to ACE inhibitors
  • Known positive test for HIV/AIDS or Hepatitis B
  • Patient is being treated for acute ulcer disease
  • History of chronic liver disease
  • Actively treated diabetes mellitis
  • Any known bleeding or platelet disorder
  • Absence of one kidney
  • Women of childbearing potential or who are breastfeeding
  • Patient is abusing or has a history of alcoholism or drug addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gradman AH, Arcuri KE, Goldberg AI, Ikeda LS, Nelson EB, Snavely DB, Sweet CS. A randomized, placebo-controlled, double-blind, parallel study of various doses of losartan potassium compared with enalapril maleate in patients with essential hypertension. Hypertension. 1995 Jun;25(6):1345-50. doi: 10.1161/01.hyp.25.6.1345.

    PMID: 7768585BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

LosartanEnalapril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesDipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Executive Vice President, Clinical and Quantitative Sciences
Organization
Merck Sharp & Dohme Corp
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 16, 2009

Study Start

December 1, 1990

Primary Completion

August 1, 1991

Study Completion

January 1, 1992

Last Updated

August 27, 2015

Results First Posted

June 10, 2009

Record last verified: 2015-08