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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134393
• Other study ID #: 1235.33
• Secondary ID: 2009-017336-40
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2010
• Last updated: December 13, 2013
• Start date: May 2010

Study information

• Verified date: December 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesItaly: Ethics CommitteeMexico: Federal Commission for Protection Against Health RisksNetherlands: Central Committee Research Involving Human SubjectsPoland: Registration Medicinal Product Medical Device Biocidal Product
• Study type: Interventional

Clinical Trial 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.

Description:

Study Design:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• telmisartan/amlodipine
start low dose and uptitrate to high dose on the basis of BP goal

Locations

Country	Name	City	State
Germany	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	Nürnberg
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
Italy	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)
Mexico	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	Mexico
Mexico	1235.33.52009 Boehringer Ingelheim Investigational Site	Mexico
Mexico	1235.33.52008 Boehringer Ingelheim Investigational Site	Monterrey
Netherlands	1235.33.31007 Boehringer Ingelheim Investigational Site	's Hertogenbosch
Netherlands	1235.33.31009 Boehringer Ingelheim Investigational Site	Almere
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
Poland	1235.33.48005 Boehringer Ingelheim Investigational Site	Chorzow
Poland	1235.33.48002 Boehringer Ingelheim Investigational Site	Czestochowa
Poland	1235.33.48003 Boehringer Ingelheim Investigational Site	Czestochowa
Poland	1235.33.48010 Boehringer Ingelheim Investigational Site	Dabrowa Gornicza
Poland	1235.33.48006 Boehringer Ingelheim Investigational Site	Grodzisk Mazowiecki
Poland	1235.33.48013 Boehringer Ingelheim Investigational Site	Oswiecim
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	Warszawa
Poland	1235.33.48007 Boehringer Ingelheim Investigational Site	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Germany,  Italy,  Mexico,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.	Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.	12 weeks	No
Secondary	BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.	Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.	4 and 8 weeks	No
Secondary	BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).	Achieving BP control with HBPM is defined as SBP<135 mmHg and DBP<85 mmHg.	Week 12	No
Secondary	Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP		weeks 4, 8 and 12	No
Secondary	Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate	Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12.	weeks 4, 8 and 12	No
Secondary	Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure		weeks 4, 8 and 12	No
Secondary	DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements	DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.	weeks 4, 8 and 12	No
Secondary	Percentage of Patients in Blood Pressure Categories Over Time	BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.	weeks 4, 8 and 12	No
Secondary	DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements	DBP control: DBP <85 mmHg, SBP control: SBP <135 mmHg, DBP response: DBP <85 mmHg or a reduction from baseline >=10 mmHg, SBP response: SBP <135 mmHg or a reduction from baseline >= 15 mmHg	weeks 4, 8 and 12	No
Secondary	Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time		weeks 4 and 8	No

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