Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00558428
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-29
• Study First Submitted QC: 2007-11-14
• Study First Posted: 2007-11-15
• Primary Completion: 2008-09
• Results First Submitted: 2009-11-13
• Results First Submitted QC: 2009-11-13
• Results First Posted: 2009-12-15
• Status Verified: 2014-05
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1098

Inclusion Criteria

1. patients aged at least 18 years at the date of signing the consent form
2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study
3. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
4. able to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's decision)
5. willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation).

Exclusion Criteria

1. 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
3. mean seated systolic blood pressure (SBP) over 200 mmHg and/or mean seated diastolic blood pressure (DBP) over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHg and/or mean seated DBP over 120 mmHg at the end of the run-in period (Visit 3)
4. any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency)
5. severe renal impairment (e.g. serum creatinine >3.0 mg/dL or >265 mcmol/L, known creatinine clearance <30mL/min or clinical markers of severe renal impairment)
6. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
7. clinically relevant hyperkalaemia
8. uncorrected volume or sodium depletion.
9. primary aldosteronism.
10. hereditary fructose or lactose intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)	End of study (8 weeks or last value on treatment)	Change from baseline to the end of study in trough DBP
Number of Patients With Oedema	During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)	Patients from the treated set who experienced at least one case of general oedema.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)	End of study (8 weeks or last value on treatment)	Change from baseline to the end of study in trough SBP
Trough Seated Diastolic Blood Pressure Control	End of study (8 weeks or last value on treatment)	The number of patients who reach the target DBP of \<90mmHg
Trough Seated DBP Response	End of study (8 weeks or last value on treatment)	The number of patients who reach the target DBP of \<90mmHg or had a reduction in DBP \>= 10mmHg
Trough Seated SBP Control	End of study (8 weeks or last value on treatment)	The number of patients who reach the target SBP of \<140mmHg
Trough Seated SBP Response	End of study (8 weeks or last value on treatment)	The number of patients who reach the target SBP of \<140mmHg or had a reduction in SBP \>= 15 mmHg
Trough Seated Blood Pressure (BP) Normality Classes	End of study (8 weeks or last value on treatment)	The number of patients who reach predefined BP categories: * Optimal - SBP\<120 and DBP\<80 mmHg; * Normal - SBP\<130 and DBP\<85 mmHg; * High-normal - SBP\<140 DBP\<90 mmHg; * Stage 1 hypertension - SBP\<160 and DBP\<100; * Stage 2 hypertension SBP\>=160 and DBP\>=100 mmHg

Trial Locations

Locations (129)

1235.5.82005 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1235.5.31008 Boehringer Ingelheim Investigational Site; 🇳🇱 Beerzerveld, Netherlands

1235.5.31006 Boehringer Ingelheim Investigational Site; 🇳🇱 Bennebroek, Netherlands

1235.5.31004 Boehringer Ingelheim Investigational Site; 🇳🇱 Hoogwoud, Netherlands

1235.5.31003 Boehringer Ingelheim Investigational Site; 🇳🇱 Musselkanaal, Netherlands

1235.5.31007 Boehringer Ingelheim Investigational Site; 🇳🇱 Nijverdal, Netherlands

1235.5.31001 Boehringer Ingelheim Investigational Site; 🇳🇱 Oude Pekela, Netherlands

1235.5.31005 Boehringer Ingelheim Investigational Site; 🇳🇱 Roelofarendsveen, Netherlands

1235.5.31010 Boehringer Ingelheim Investigational Site; 🇳🇱 Voerendaal, Netherlands

1235.5.47002 Boehringer Ingelheim Investigational Site; 🇳🇴 Bergen, Norway

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