Efficacy and Safety of Telmisartan in Hypertensive Patients With Mild/Moderate or Severe Renal Impairment or Requiring Hemodialysis
ESPRIT
An Open-labeled, Placebo run-in, Multicentre Study to Investigate the Efficacy and Safety of Telmisartan (40 and 80 mg QD p.o.) in 3 Strata of Mild to Moderate Hypertensive Patients (Sitting Diastolic Blood Pressure ≥ 90 mmHg and ≤ 109 mmHg From Office Cuff Measurement) With Mild/Moderate or Severe Renal Impairment or Requiring Maintenance Hemodialysis. (ESPRIT Study = Efficacy and Safety in Patients With Renal Impairment Treated With Telmisartan)
1 other identifier
interventional
82
0 countries
N/A
Brief Summary
To evaluate the safety and efficacy, in particular with regard to renal function of telmisartan at the doses of 40 mg and 80 mg in hypertensive patients with moderate to endstage renal impairment after 12 weeks of treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hypertension
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, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 27, 2014
CompletedFirst Posted
Study publicly available on registry
June 30, 2014
CompletedJune 30, 2014
June 1, 2014
1.6 years
June 27, 2014
June 27, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Changes from baseline in seated diastolic blood pressure (DBP) at trough
12 weeks after start of treatment
Secondary Outcomes (8)
Change from baseline in seated systolic blood pressure (SBP) at trough
12 weeks after start of treatment
Frequency of response categories of blood pressure
After 12 weeks of treatment
Changes from baseline in proteinuria
12 weeks after start of treatment
Change in electrolyte excretion
12 weeks after start of treatment
Area under the telmisartan plasma concentration-time curve
Day 7 and 12 weeks after start of treatment
- +3 more secondary outcomes
Study Arms (1)
Telmisartan
EXPERIMENTALInterventions
patients switch to high dose if mean SBP \>= 85 mmHg after 4 weeks of treatment
Eligibility Criteria
You may qualify if:
- Mild to moderate hypertension, sitting diastolic BP ≥ 90 mmHg and BP ≤ 109 mmHg at visit 2
- No increase of serum creatinine over 30% within 6 months before the trial
- Stable renal insufficiency with a serum creatinine between 200 and 600 µmol/l or maintenance of hemodialysis
- Stable proteinuria of at least 500 mg/24h
- No change in hemodialysis regimen within the last two months prior to visit 1
- years of age or more
- Ability to provide written informed consent in accordance with good clinical practice and local registration
- Able to stop current antihypertensive therapy (ACE-Inhibitors or angiotensin II receptor subtype 1- Blocker) without risk to the patient
You may not qualify if:
- Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in-phase) who:
- are not surgically sterile; and/or
- are nursing
- are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of ≥ 3-months duration. Acceptable methods of birth control include oral, implantable or injectable contraceptives
- Known or suspected renovascular hypertension
- Mean sitting SBP ≥ 180 mmHg or mean sitting DBP ≥110 mmHg during any visit of the placebo run-in phase
- Hepatic dysfunction as defined by the following laboratory parameters:
- serum glutamate pyruvate transaminase (ALT) or serum glutamate oxaloacetate transaminase (AST) \> than 2 times the upper limit of normal range
- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney, patients postrenal transplant or with only one kidney
- Clinically relevant hypo- or hyperkalaemia
- Uncorrected volume depletion
- Uncorrected sodium depletion
- Primary aldosteronism
- Hereditary fructose intolerance
- Biliary obstructive disorders
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2014
First Posted
June 30, 2014
Study Start
September 1, 2000
Primary Completion
April 1, 2002
Last Updated
June 30, 2014
Record last verified: 2014-06