Efficacy and Safety of Telmisartan in Hypertensive Patients With Mild/Moderate or Severe Renal Impairment or Requiring Hemodialysis (ESPRIT)

June 27, 2014 updated by: Boehringer Ingelheim

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)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Mild to moderate hypertension, sitting diastolic BP ≥ 90 mmHg and BP ≤ 109 mmHg at visit 2
  2. No increase of serum creatinine over 30% within 6 months before the trial
  3. Stable renal insufficiency with a serum creatinine between 200 and 600 µmol/l or maintenance of hemodialysis
  4. Stable proteinuria of at least 500 mg/24h
  5. No change in hemodialysis regimen within the last two months prior to visit 1
  6. 18 years of age or more
  7. Ability to provide written informed consent in accordance with good clinical practice and local registration
  8. Able to stop current antihypertensive therapy (ACE-Inhibitors or angiotensin II receptor subtype 1- Blocker) without risk to the patient

Exclusion Criteria:

  1. Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in-phase) who:

    1. are not surgically sterile; and/or
    2. are nursing
    3. 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
  2. Known or suspected renovascular hypertension
  3. Mean sitting SBP ≥ 180 mmHg or mean sitting DBP ≥110 mmHg during any visit of the placebo run-in phase

  4. 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

  5. Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney, patients postrenal transplant or with only one kidney
  6. Clinically relevant hypo- or hyperkalaemia
  7. Uncorrected volume depletion
  8. Uncorrected sodium depletion
  9. Primary aldosteronism
  10. Hereditary fructose intolerance
  11. Biliary obstructive disorders
  12. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II antagonists
  13. History of drug or alcohol abuse within 6 months
  14. Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol (ß-blocker, alpha-blocker, calcium antagonists, clonidine, minoxidil, and diuretics)
  15. Any investigational therapy within one month of signing the informed consent form
  16. Known hypersensitivity to any component of the formulation
  17. Has no contra-indication to a placebo run-in period (e.g. unstable angina within the past 3 months, stroke within the past 6 months or myocardial infarction or cardiac surgery within the past 3 months)
  18. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan
  19. Compliance < 70% during run-in period (defined by pill count)
  20. History of heart failure, malignancy, or any disorders requiring immunosuppressive therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telmisartan
Drug: Telmisartan low dose
Drug: Telmisartan high dose
patients switch to high dose if mean SBP >= 85 mmHg after 4 weeks of treatment
Drug: Placebo
Run-in phase

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes from baseline in seated diastolic blood pressure (DBP) at trough
Time Frame: 12 weeks after start of treatment
12 weeks after start of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in seated systolic blood pressure (SBP) at trough
Time Frame: 12 weeks after start of treatment
12 weeks after start of treatment
Frequency of response categories of blood pressure
Time Frame: After 12 weeks of treatment

Categories:

  1. BP normal
  2. DBP control
  3. DBP response
  4. SBP response
  5. BP high normal
After 12 weeks of treatment
Changes from baseline in proteinuria
Time Frame: 12 weeks after start of treatment
12 weeks after start of treatment
Change in electrolyte excretion
Time Frame: 12 weeks after start of treatment
12 weeks after start of treatment
Area under the telmisartan plasma concentration-time curve
Time Frame: Day 7 and 12 weeks after start of treatment
Day 7 and 12 weeks after start of treatment
Maximum plasma concentration (Cmax) of telmisartan
Time Frame: Day 7 and 12 weeks after start of treatment
Day 7 and 12 weeks after start of treatment
Time to peak (Tmax) plasma concentrations of telmisartan
Time Frame: Day 7 and 12 weeks after start of treatment
Day 7 and 12 weeks after start of treatment
Extent of protein binding of telmisartan
Time Frame: Day 7 and 12 weeks after start of treatment
equilibrium dialysis with subsequent determination of protein-bound telmisartan fraction
Day 7 and 12 weeks after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2000

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2002

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 502.339

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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