Open-label Follow-up Trial of Fixed Dose Combination of Telmisartan 80 mg + Hydrochlorothiazide 25 mg - Full Text View

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00267943

Purpose

The primary objective is to assess the efficacy and safety of the fixed dose combination of telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) alone or in addition to other antihypertensive therapies during open-label, long-term treatment.

Condition	Intervention	Phase
Hypertension	Drug: telmisartan 80 mg + hydrochlorothiazide 25 mg	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 80 mg + Hydrochlorothiazide 25 mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Hydrochlorothiazide Telmisartan

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP < 90 mmHg at trough i.e., 24 hours after last dose) at six months of treatment.

Secondary Outcome Measures:

The secondary efficacy endpoint variables include a range of blood pressure measurements e.g., seated trough systolic blood pressure. Safety (vital signs, laboratory values, physical examination and ECG findings) will also be assessed.

Estimated Enrollment:	480
Estimated Study Completion Date:	January 2007

Detailed Description:

Patients with a history of hypertension who completed a preceding trial (number 502.480) within the previous fourteen (14) days will be considered for entry to this long-term open-label trial. All patients will receive 'T80/H25'. Additional antihypertensive therapy will be allowed if the patients' blood pressure is not well controlled. [In the preceding double-blind trial 502.480, patients who failed to respond to the fixed dose combination of telmisartan 80 mg '+' hydrochlorothiazide 12.5 mg (T80/H12.5) were randomised to 'T80/H12.5' or T80H25 for eight weeks.] This is a multi-centre, multinational trial with approximately 80 study centres participating. Only study centres participating in the preceding trial 502.480 can enter patients into this open-label trial. It is anticipated that a maximum of 480 patients will be entered into the trial in seventeen countries. Each trial centre is expected to enter between four and twenty-four patients.

Enrollment of patients into this trial will finish when the last patient completes the preceding trial 502.480. At this time, centres will be notified of the termination of recruitment and will not be authorized to include any further patients.

Patients will visit the clinic one month, three months and six months later for assessment of their blood pressure and general health. Their participation in the study is complete six months after the start of the treatment period.

Study Hypothesis:

No statistical hypothesis will be tested. Descriptive statistics will be used to characterise the effects of treatment with T80/H25 with and without other antihypertensive treatments.

Comparison(s):

The proportion of patients achieving DBP control will be summarised by the total number of patients in the trial as well as by the maximum achieved dose level according to the two categories of T80/H25 alone (T80/H25) and with other antihypertensive medication added (T80/H25/other). An additional sub-group summary by the treatment group in the preceding trial 502.480 (T80/H12.5 and T80/H25) will also be presented.

Eligibility

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

Criteria

Inclusion criteria:

Essential hypertension.
Currently taking between one and three antihypertensive medications at a stable dose for at least four weeks before Visit 1 of preceding trial 502.480.
Blood pressure not adequately controlled on existing treatment before entry to preceding trial 502.480 (inadequate control defined as seated DBP >= 95 mmHg on one current antihypertensive medication or DBP >= 90 mmHg on two or more current antihypertensive medications).
Failure to respond to six weeks run-in treatment with T80/H12.5 in preceding trial 502.480. (Failure to respond defined as seated DBP >= 90 mmHg.)
Willing and able to provide written informed consent.

Exclusion criteria:

Women of child-bearing potential NOT practising acceptable means of birth control, positive serum pregnancy test, breastfeeding.
Known or suspected secondary hypertension.
Clinically significant change in ECG reported as adverse event in preceding trial 502.480.
Any medical condition developing in preceding trial 502.480 that could be worsened by telmisartan/HCTZ (80/25).
Discontinuation from preceding 502.480 trial for adverse event or any other reason.
Mean SBP >= 200 mmHg.
Severe hepatic or renal impairment.
Bilateral renal artery stenosis (or in a solitary kidney), post-renal transplant or only one functioning kidney.
Clinically relevant hypokalaemia or hyperkalaemia.
Uncorrected volume or sodium depletion, primary aldosteronism.
Hereditary fructose intolerance.
Previous symptoms of angioedema after ACE inhibitors or angiotensin-II receptor antagonists.
Drug or alcohol dependency within the six months prior to entry to 502.480. concurrent participation in another clinical trial or any investigational therapy.
Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
Allergic hypersensitivity to any component of the formulations under investigation.
Concomitant therapy with lithium, cholestyramine or colestipol resins.
Non-compliance with study medication (less than 80% or more than 120%) during the preceding 502.480 trial.
Any other clinical condition which, in the opinion of the investigator, would not allow safe administration of telmisartan or hydrochlorothiazide.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267943

Show 78 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

BIL UK / Ireland

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Boehringer Ingelheim Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Neldam S, Edwards C. Long-term, open-label evaluation of the safety and efficacy of telmisartan 80 mg/hydrochlorothiazide 25 mg fixed-dose combination alone or with other antihypertensive medication. Expert Opin Pharmacother. 2009 Feb;10(3):345-52.

ClinicalTrials.gov Identifier:	NCT00267943 History of Changes
Other Study ID Numbers:	502.491
Study First Received:	December 21, 2005
Last Updated:	October 7, 2009
Health Authority:	Spain: Spanish Agency of Medicines; France: French Medicine Agency (AFSSAPS); Ireland: Irish Medicines Board; Italy: Ethics Committee; Norway: Norwegian Medicines Agency; Korea, Republic of: Centre for Pharmaceutical Administration, Health Science Authority; Korea, Republic of: National Pharmaceutical Control Bureau, Malaysia; Korea: Food and Drug Administration; Switzerland: Swissmedic; Sweden: Laekemedelsverket; South Africa: Medicines Control Council; Denmark: Laegemiddelstyrelsen Clinical Studies; Germany: Bundesministerium fuer Arzneimittel und Medizinprodukte; Netherlands: No regulatory agency approval needed for clinical trials; Finland: Laeaekelaitos, National Agency for Medicines, Mannerheimintie 103b, P.O.Box 55, FI-00301

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Hydrochlorothiazide
Telmisartan
Benzoates
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents

Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 09, 2012