Status:
COMPLETED
26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during ...
Eligibility Criteria
Inclusion
- \- diagnosis of essential hypertension
Exclusion
- pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
- development of any condition in the preceding trial that could be worsened by telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10).
- discontinuation from the preceding trial.
- known or suspected secondary hypertension.
- mean seated systolic blood pressure (SBP) \>= 180 mmHg and/or mean seated diastolic blood pressure (DBP) \>= 120 mmHg at any visit.
- any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
- clinically relevant hyperkalaemia.
- uncorrected volume or sodium depletion.
- primary aldosteronism.
- hereditary fructose or lactose intolerance.
- symptomatic congestive heart failure.
- patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
- any new drug or alcohol dependency since signing consent of the preceding trial.
- concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial.
- hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
- known allergic hypersensitivity to any component of the formulations under investigation. \[Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine calcium channel blockers (CCBs).\] non-compliance with study medication (defined as \<80% or \>120%) during the preceding trial.
- administration of ARBs or dihydropyridine CCBs (apart from trial medication). any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
838 Patients enrolled
Trial Details
Trial ID
NCT00624052
Start Date
March 1 2008
Last Update
May 20 2014
Active Locations (92)
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1
1235.8.61003 Boehringer Ingelheim Investigational Site
Gosford, New South Wales, Australia
2
1235.8.61004 Boehringer Ingelheim Investigational Site
Liverpool, New South Wales, Australia
3
1235.8.61002 Boehringer Ingelheim Investigational Site
Kippa-Ring, Queensland, Australia
4
1235.8.61001 Boehringer Ingelheim Investigational Site
Milton, Queensland, Australia