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TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch | Clinical Trials | Clareo Health

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TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch

A Prospective, Open-label TElmisartan/AMlodipine Single Pill STudy to Assess the Efficacy in Patients With Essential Hypertension"..."

NCT01134393•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The general aim of this trial to determine the efficacy as measured by the percentage of patients reaching blood pressure goal at the end of the treatment period at 12 weeks. In-clinic blood pressures, home blood pressures and safety will be carefully monitored.

Detailed Description

Study Design:

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
•2. Age 18 years or older
•3. Patients with uncontrolled hypertension as defined SBP \> 140 mmHg and SBP \> 130 mmHg in patients with diabetes or renal impairment or DBP \> 90 mmHg and DBP \>80 mmHg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single RAAS blocking agent (Angiotensin Converting Enzym inhibition, AII Receptor Blocker and Direct Renin Inhibitor) at entering the trial. Renal impairment is defined as a creatinine \>133µmol/l (1.5mg/dl) in male patients and a creatinine \>124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min

Exclusion Criteria

•1. Pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
•2. Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma).
•3. Mean in-clinic seated cuff Systolic BP \>180 mmHg and SBP \>160 mmHg in patients with diabetes or renal impairment or Diastolic BP \>110 mmHg and DBP \>100 mmHg in patients with diabetes or renal impairment. Renal impairment is defined as a creatinine \>133µmol/l (1.5mg/dl) in male patients and a creatinine \>124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min.
•4. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine \>3.0 mg/dl (or \>265 ¿mol/L) and/or known creatinine clearance of \<30 ml/min and/or clinical markers of severe renal impairment.
•5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
•6. Clinically relevant hypokalaemia or hyperkalaemia (i.e., \<3.5 or \>5.5 mEq/L).
•7. Uncorrected sodium or volume depletion.
•8. Primary aldosteronism.
•9. Hereditary fructose intolerance.
•10. Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.1).
+8 more criteria

Locations (47)

1235.33.49010 Boehringer Ingelheim Investigational Site

Berlin, Germany

1235.33.49002 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

1235.33.49007 Boehringer Ingelheim Investigational Site

Haag, Germany

1235.33.49003 Boehringer Ingelheim Investigational Site

Heidelberg, Germany

1235.33.49005 Boehringer Ingelheim Investigational Site

Künzing, Germany

1235.33.49008 Boehringer Ingelheim Investigational Site

Nuremberg, Germany

1235.33.49009 Boehringer Ingelheim Investigational Site

Rednitzhembach, Germany

1235.33.49006 Boehringer Ingelheim Investigational Site

Rodgau-Dudenhofen, Germany

1235.33.49004 Boehringer Ingelheim Investigational Site

Unterschneidheim, Germany

1235.33.49001 Boehringer Ingelheim Investigational Site

Westerkappeln, Germany

Key Dates

Start Date

May 1, 2010

Primary Completion Date

May 1, 2011

Last Updated

January 15, 2014

Enrollment

502

ACTUAL participants

Conditions

Hypertension

Interventions

telmisartan/amlodipine

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch

Inclusion Criteria

Exclusion Criteria

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