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

NCT ID: NCT01134393

Last Updated: 2014-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31

Brief 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:

Conditions

Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

telmisartan/amlodipine

start low dose and uptitrate to high dose on the basis of blood pressure goal

Group Type: EXPERIMENTAL

telmisartan/amlodipine

Intervention Type: DRUG

start low dose and uptitrate to high dose on the basis of BP goal

Interventions

telmisartan/amlodipine

start low dose and uptitrate to high dose on the basis of BP goal

Intervention Type: DRUG

Eligibility Criteria

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).

11. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator.

12. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of >2x bilirubin or >2x transaminases values). (Refer to Appendix 10.3)

13. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists.

14. History of drug or alcohol dependency within six months prior to signing the informed consent form.

15. Any investigational drug therapy within one month of signing the informed consent.

16. Known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine).

17. History of non-compliance or inability to comply with prescribed medications or protocol procedures.

18. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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

1235.33.39009 Boehringer Ingelheim Investigational Site

Arezzo, , Italy

1235.33.39002 Boehringer Ingelheim Investigational Site

Bologna, , Italy

1235.33.39004 Boehringer Ingelheim Investigational Site

Ferrara, , Italy

1235.33.39006 Boehringer Ingelheim Investigational Site

L’Aquila, , Italy

1235.33.39007 Boehringer Ingelheim Investigational Site

Napoli, , Italy

1235.33.39001 Boehringer Ingelheim Investigational Site

Pisa, , Italy

1235.33.39008 Boehringer Ingelheim Investigational Site

Roma, , Italy

1235.33.39005 Boehringer Ingelheim Investigational Site

Stradella (PV), , Italy

1235.33.52004 Boehringer Ingelheim Investigational Site

Aguascalientes, , Mexico

1235.33.52002 Boehringer Ingelheim Investigational Site

Durango, , Mexico

1235.33.52001 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

1235.33.52003 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

1235.33.52007 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

1235.33.52006 Boehringer Ingelheim Investigational Site

México, , Mexico

1235.33.52009 Boehringer Ingelheim Investigational Site

México, , Mexico

1235.33.52008 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

1235.33.31007 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, , Netherlands

1235.33.31009 Boehringer Ingelheim Investigational Site

Almere Stad, , Netherlands

1235.33.31005 Boehringer Ingelheim Investigational Site

Beek en Donk, , Netherlands

1235.33.31002 Boehringer Ingelheim Investigational Site

Beerzerveld, , Netherlands

1235.33.31008 Boehringer Ingelheim Investigational Site

Ermelo, , Netherlands

1235.33.31006 Boehringer Ingelheim Investigational Site

Lichtenvoorde, , Netherlands

1235.33.31001 Boehringer Ingelheim Investigational Site

Musselkanaal, , Netherlands

1235.33.31004 Boehringer Ingelheim Investigational Site

Nijverdal, , Netherlands

1235.33.31003 Boehringer Ingelheim Investigational Site

Wildervank, , Netherlands

1235.33.48005 Boehringer Ingelheim Investigational Site

Chorzów, , Poland

1235.33.48002 Boehringer Ingelheim Investigational Site

Częstochowa, , Poland

1235.33.48003 Boehringer Ingelheim Investigational Site

Częstochowa, , Poland

1235.33.48010 Boehringer Ingelheim Investigational Site

Dąbrowa Górnicza, , Poland

1235.33.48006 Boehringer Ingelheim Investigational Site

Grodzisk Mazowiecki, , Poland

1235.33.48013 Boehringer Ingelheim Investigational Site

Oświęcim, , Poland

1235.33.48008 Boehringer Ingelheim Investigational Site

Piotrkow Trybunalski, , Poland

1235.33.48004 Boehringer Ingelheim Investigational Site

Poznan, , Poland

1235.33.48001 Boehringer Ingelheim Investigational Site

Tychy, , Poland

1235.33.48009 Boehringer Ingelheim Investigational Site

Tychy, , Poland

1235.33.48011 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

1235.33.48007 Boehringer Ingelheim Investigational Site

Wroclaw, , Poland

Countries

Germany; Italy; Mexico; Netherlands; Poland

Other Identifiers

2009-017336-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1235.33

Identifier Type: -

Identifier Source: org_study_id