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

Hypertension Clinical Trial

— ESPRIT  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178306
• Other study ID #: 502.339
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2014
• Last updated: June 27, 2014
• Start date: September 2000

Study information

• Verified date: June 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesFrance: Agence Nationale de Sécurité du Médicament et des produits de santéNetherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Renal Insufficiency

Intervention

Drug:
• Telmisartan low dose

• Telmisartan high dose
patients switch to high dose if mean SBP >= 85 mmHg after 4 weeks of treatment
• Placebo
Run-in phase

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in seated diastolic blood pressure (DBP) at trough		12 weeks after start of treatment	No
Secondary	Change from baseline in seated systolic blood pressure (SBP) at trough		12 weeks after start of treatment	No
Secondary	Frequency of response categories of blood pressure	Categories: BP normal; DBP control; DBP response; SBP response; BP high normal	After 12 weeks of treatment	No
Secondary	Changes from baseline in proteinuria		12 weeks after start of treatment	No
Secondary	Change in electrolyte excretion		12 weeks after start of treatment	No
Secondary	Area under the telmisartan plasma concentration-time curve		Day 7 and 12 weeks after start of treatment
Secondary	Maximum plasma concentration (Cmax) of telmisartan		Day 7 and 12 weeks after start of treatment	No
Secondary	Time to peak (Tmax) plasma concentrations of telmisartan		Day 7 and 12 weeks after start of treatment	No
Secondary	Extent of protein binding of telmisartan	equilibrium dialysis with subsequent determination of protein-bound telmisartan fraction	Day 7 and 12 weeks after start of treatment	No

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