NCT02242370

Brief Summary

Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to establish the effect on patient's quality of life scores.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,045

participants targeted

Target at P75+ for phase_4 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

September 1, 1999

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
13.9 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

1.2 years

First QC Date

September 16, 2014

Last Update Submit

September 16, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

  • Change in diastolic blood pressure

    Pre-dose, up to 6 weeks after start of treatment

  • Change in systolic blood pressure

    Pre-dose, up to 6 weeks after start of treatment

  • Changes from baseline in the quality of life (QOL) scores by patient self-assessment

    Pre-dose, 6 weeks after start of treatment

Secondary Outcomes (5)

  • Assessment of blood pressure control rate

    Up to 6 weeks after start of treatment

  • Assessment of systolic blood pressure response rate

    Up to 6 weeks after start of treatment

  • Assessment of diastolic blood pressure response rate

    Up to 6 weeks after start of treatment

  • Change from baseline in pulse pressure

    Pre-dose, up to 6 weeks after start of treatment

  • Number of patients with adverse events

    Up to 6 weeks

Study Arms (2)

Telmisartan low dose

EXPERIMENTAL
Drug: Low dose of telmisartan

Telmisartan high dose

EXPERIMENTAL
Drug: High dose of telmisartan

Interventions

Low dose of telmisartanDRUG
Telmisartan low dose
High dose of telmisartanDRUG
Telmisartan high dose

Eligibility Criteria

Age20 Years - 93 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Stage I essential Hypertension (diastolic blood pressure 90-99 mmHg, and/or systolic blood pressure 140-159 mmHg)
  • Signed informed consent form

You may not qualify if:

  • \- Females of childbearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 17, 2014

Study Start

September 1, 1999

Primary Completion

November 1, 2000

Last Updated

September 17, 2014

Record last verified: 2014-09