Open-Label Follow-up Trial of Fixed Dose Combination of Telmisartan 80 mg + Hydrochlorothiazide 25 mg

Condition(s) targeted: Hypertension

Intervention: telmisartan 80mg + hydrochlorothiazide 25mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: BIL UK / Ireland

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 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: 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.

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 pat ients will receive 'T80/H25'. Additional antihypertensive therapy will be allowed if the patients' blo od pressure is not well controlled. [In the preceding double-blind trial 502. 480, patients who fail ed 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 t rial. It is anticipated that a maximum of 480 patients will be entered into the trial in seventeen c ountries. Each trial centre is expected to enter between four and twenty-four patients.

Enrolment of patients into this trial will finish when the last patient completes the preceding tria l 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 hypothesies will be tested. Descriptive statistics will be used t

o characterise the effects of treatment with T80/H25 with and without other anti hypertensive 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 a ccording to the two categories of T80/H25 alone (T80/H25) and with other antihyp ertensive medication added (T80/H25/other). An additional sub-group summary by t he treatment group in the preceding trial 502. 480 (T80/H12. 5 and T80/H25) will a lso be presented.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Essential hypertension.

- Currently taking between one and three antihypertensive medications at a stable

- Dose for at least four weeks before Visit 1of 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 therap y.

- 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.

Boehringer Ingelheim Investigational Site, R?dovre DK-2600, Denmark

Boehringer Ingelheim Investigational Site, Birker?d 3460, Denmark

Boehringer Ingelheim Investigational Site, Odder 8300, Denmark

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Boehringer Ingelheim Investigational Site, Joensuu FI-80100, Finland

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Hopital Avicenne, Bobigny 93000, France

mg Recherches, Paris 75000, France

mg Recherches, Paris 75015, France

ALTI, Angers 49000, France

Boehringer Ingelheim Investigational Site, Unterschneidheim 73485, Germany

Boehringer Ingelheim Investigational Site, Frankfurt/Main 60323, Germany

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Ospedale Arnaboldi, BRONI (PV) 27043, Italy

Azienda Ospedaliera Universita di Ferrara, FERRARA 44100, Italy

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Hospital Gral de Jerez de la Frontera, Jerez de la Frontera / Cadiz 11407, Spain

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Hospital de Galdakao, Galdakao / Vizcaya 48680, Spain

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Ending date: January 2007
Last updated: April 4, 2008