NCT02269176

Brief Summary

Using Losartan as a comparator, to evaluate the efficacy and safety of telmisartan in the treatment of the mild to moderate primary hypertension patients in China

Trial Health

100
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P50-P75 for phase_3 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2001

Completed
13.8 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

October 20, 2014

Last Update Submit

October 20, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Changes in mean sitting valley value of DBP

    The valley value of blood pressure refers to the blood pressure measured prior to the next administration of antihypertensives

    8 weeks after start of treatment

Study Arms (2)

Telmisartan

EXPERIMENTAL

Low dose of telmisartan, uptitrated to high dose in case no sufficient effect is observered

Drug: Low dose of telmisartanDrug: High dose of telmisartan

Losartan

ACTIVE COMPARATOR

Low dose of losartan, uptitrated to high dose in case no sufficient effect is observered

Drug: Low dose of losartanDrug: High dose of losartan

Interventions

Low dose of telmisartanDRUG
Telmisartan
High dose of telmisartanDRUG
Telmisartan
Low dose of losartanDRUG
Losartan
High dose of losartanDRUG
Losartan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Mild to moderate primary hypertension, the mean sitting valley value of diastolic blood pressure (DBP) ≥ 95 and \< 110 mmHg, and the mean sitting valley value of systolic blood pressure (SBP) \< 180 mmHg

You may not qualify if:

  • \- Not specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

TelmisartanLosartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingTetrazoles

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

October 20, 2014

First Posted

October 21, 2014

Study Start

July 1, 2000

Primary Completion

January 1, 2001

Last Updated

October 21, 2014

Record last verified: 2014-10