NCT02177500

Brief Summary

An eight week study to compare the effect of a fixed dose combination of Telmisartan 40 mg plus hydrochlorothiazide (HCTZ) 12.5 mg to Telmisartan 40 mg alone on diastolic and systolic blood pressure in patients who fail to respond adequately to telmisartan monotherapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
327

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2000

Completed
14.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

4 months

First QC Date

June 26, 2014

Last Update Submit

July 7, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in seated diastolic blood pressure (DBP)

    baseline and after 8 weeks of treatment

Secondary Outcomes (8)

  • Change from baseline in seated systolic blood pressure (SBP)

    baseline and after 8 weeks of treatment

  • Blood pressure control

    8 weeks

  • Systolic blood pressure response

    8 weeks

  • Incidence of adverse events

    up to 16 weeks

  • Change from baseline in physical examination

    Baseline and day 56

  • +3 more secondary outcomes

Study Arms (2)

Telmisartan + hydrochlorothiazide and matching placebo

EXPERIMENTAL
Drug: Telmisartan + hydrochlorothiazideDrug: Placebo

Telmisartan and matching placebo

EXPERIMENTAL
Drug: TelmisartanDrug: Placebo

Interventions

Telmisartan + hydrochlorothiazideDRUG
Telmisartan + hydrochlorothiazide and matching placebo
TelmisartanDRUG
Telmisartan and matching placebo
PlaceboDRUG
Telmisartan + hydrochlorothiazide and matching placeboTelmisartan and matching placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of mild-to-moderate hypertension
  • Patients who fail to respond adequately to telmisartan monotherapy
  • Participants between 18 and 80 years of age
  • Willingness and ability to provide written informed consent

You may not qualify if:

  • Patients taking more than three anti-hypertensive medications at the screening visit
  • Pre-menopausal women
  • Who are not surgically sterile
  • Who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study. Acceptable methods of birth control include intrauterine device (IUD), oral, implantable or injectable contraceptives
  • Any women:
  • Who has a positive serum pregnancy test at screening (Visit 1) or baseline (Visit 3)
  • Who is nursing
  • Hepatic and/or renal dysfunction as defined by the following laboratory parameters
  • SGPT (serum glutamate pyruvate transaminase) or SGOT (serum glutamate oxaloacetate transaminase) greater than two times the upper limit of normal
  • Serum creatinine \> 2.3 mg/dL
  • Clinically relevant sodium depletion, hyperkalemia, or hypokalemia at baseline
  • Known or suspected secondary hypertension
  • Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
  • Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF III-IV)
  • Unstable angina within the past three months
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

telmisartan, hydrochlorothiazide drug combinationTelmisartan

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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2014

First Posted

June 27, 2014

Study Start

January 1, 2000

Primary Completion

May 1, 2000

Last Updated

July 8, 2014

Record last verified: 2014-07