Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension - Full Text View

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00558428

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: fixed dose combination of telmisartan+amlodipine Drug: amlodipine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Eight-Week Randomized, 4-Arm, Double-Blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy

Resource links provided by NLM:

MedlinePlus related topics: Edema High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Telmisartan

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The co primary endpoints are the change from baseline in DBP and the rate of incidence of oedema adverse events. [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

the change from baseline in seated SBP. the proportion of patients achieving DBP control [ Time Frame: 8 weeks ]

Enrollment:	1098
Study Start Date:	October 2007
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
known or suspected secondary hypertension
mean seated SBP over 200 mmHg and/or mean seated 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)
any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency)
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)
bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
clinically relevant hyperkalaemia
uncorrected volume or sodium depletion.
primary aldosteronism.
hereditary fructose or lactose intolerance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558428

Show 129 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1235.5, EUDRACT2007-002409-36
Study First Received:	October 29, 2007
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00558428 History of Changes
Health Authority:	Belgium: Federal Agency for Medicines and Health Products; Canada: Health Canada (TPD); Denmark: Lægemiddelstyrelsen Kliniskeforsøg, Inspektionen Axel Heides Gade 1 DK-2300 Copenhagen S; Finland: HUS Ethics Committee; France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE; Korea, Republic of: Korea Food and Drug Administration (KFDA); Netherlands: Central Committee on Research Involving Human Subjects (CCMO); Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Philippines: Department of Health, Republic of the Philippines; South Africa: Medicines Control Council; Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency; Taiwan: Department of Health, Executive Yuan, Taiwan; United States: Food and Drug Administration

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Hypertension

ClinicalTrials.gov processed this record on November 20, 2009