Open-label Follow-up Trial of Fixed Dose Combination of Telmisartan + Hydrochlorothiazide in Hypertensive Patients

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.

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: telmisartan 80 mg + hydrochlorothiazide 25 mg

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.

• Study Type: Interventional
• Enrollment: 639
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Birker?d, Denmark, 3460
    • Boehringer Ingelheim Investigational Site
  • Haderslev, Denmark, DK-6100
    • Boehringer Ingelheim Investigational Site
  • Odder, Denmark, 8300
    • Boehringer Ingelheim Investigational Site
  • R?dovre, Denmark, DK-2600
    • Boehringer Ingelheim Investigational Site
  • Vildbjerg, Denmark, DK-7480
    • Boehringer Ingelheim Investigational Site
• Finland
  • Helsinki, Finland, FI-00500
    • Boehringer Ingelheim Investigational Site
  • Joensuu, Finland, FI-80100
    • Boehringer Ingelheim Investigational Site
  • Turku, Finland, FI-20100
    • Boehringer Ingelheim Investigational Site
  • Turku, Finland, FI-20520
    • Boehringer Ingelheim Investigational Site
• France
  • Angers, France, 49000
    • ALTI
  • Bobigny, France, 93000
    • Hôpital Avicenne
  • Paris, France, 75000
    • Mg Recherches
  • Paris, France, 75015
    • Mg Recherches
• Germany
  • Ellefeld, Germany, 08236
    • Boehringer Ingelheim Investigational Site
  • Florsheim, Germany, 65439
    • Boehringer Ingelheim Investigational Site
  • Frankfurt/Main, Germany, 60323
    • Boehringer Ingelheim Investigational Site
  • Haag, Germany, 83527
    • Boehringer Ingelheim Investigational Site
  • Ingelheim, Germany, 55218
    • Boehringer Ingelheim Investigational Site
  • Nurnberg, Germany, 90402
    • Boehringer Ingelheim Investigational Site
  • Rodgau-Dudenhofen, Germany, 63110
    • Boehringer Ingelheim Investigational Site
  • Unterschneidheim, Germany, 73485
    • Boehringer Ingelheim Investigational Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Boehringer Ingelheim Investigational Site
• Ireland
  • Birr, Ireland
    • Boehringer Ingelheim Investigational Site
  • Carrigallen, Ireland
    • Boehringer Ingelheim Investigational Site
  • Dublin 18, Ireland
    • Boehringer Ingelheim Investigational Site
  • Gorey, Ireland
    • Boehringer Ingelheim Investigational Site
  • Mallow, Ireland
    • Boehringer Ingelheim Investigational Site
  • New Ross, Ireland
    • Boehringer Ingelheim Investigational Site
  • Templeshannon, Ireland
    • Boehringer Ingelheim Investigational Site
• Italy
  • Broni (pv), Italy, 27043
    • Ospedale Arnaboldi
  • Ferrara, Italy, 44100
    • Azienda Ospedaliera Universita di Ferrara
  • Roma, Italy, 00163
    • IRCCS San Raffaele
  • Vittorio Veneto (tv), Italy, 31029
    • Ospedale Civile
• Korea, Republic of
  • Incheon, Korea, Republic of, 405760
    • Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of, 134701
    • Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of, 152703
    • Boehringer Ingelheim Investigational Site
• Malaysia
  • Kuching, Sarawak, Malaysia, 93586
    • Boehringer Ingelheim Investigational Site
• Netherlands
  • Beerzeveld, Netherlands, 7685 PG
    • Boehringer Ingelheim Investigational Site
  • Bennebroek, Netherlands, 2121 BB
    • Boehringer Ingelheim Investigational Site
  • Ewijk, Netherlands, 6644 CL
    • Boehringer Ingelheim Investigational Site
  • Hoogwoud, Netherlands, 1817 BG
    • Boehringer Ingelheim Investigational Site
  • Nijverdal, Netherlands, 7441 BN
    • Boehringer Ingelheim Investigational Site
  • Oude Pekela, Netherlands, 9665 BJ
    • Boehringer Ingelheim Investigational Site
  • Oude Pekela, Netherlands, 9665 AR
    • Boehringer Ingelheim Investigational Site
  • Rijswijk, Netherlands, 2281 AK
    • Boehringer Ingelheim Investigational Site
  • Roelofarendsveen, Netherlands, 2371 RB
    • Boehringer Ingelheim Investigational Site
  • Rotterdam, Netherlands, 3082 DC
    • Boehringer Ingelheim Investigational Site
• Norway
  • Elverum, Norway, N-2408
    • Boehringer Ingelheim Investigational Site
  • Moelv, Norway, N-2391
    • Boehringer Ingelheim Investigational Site
  • Oslo, Norway, N-0369
    • Boehringer Ingelheim Investigational Site
  • Skedsmokorset, Norway, N-2020
    • Boehringer Ingelheim Investigational Site
• South Africa
  • Bellville, South Africa, 7531
    • Boehringer Ingelheim Investigational Site
  • Durban, South Africa, 4001
    • Boehringer Ingelheim Investigational Site
  • Lenasia, South Africa, 2033
    • Boehringer Ingelheim Investigational Site
  • Lenasia South, South Africa, 2033
    • Boehringer Ingelheim Investigational Site
  • Midrand, South Africa, 1685
    • Boehringer Ingelheim Investigational Site
  • Newtown, South Africa, 2001
    • Boehringer Ingelheim Investigational Site
  • Pretoria, South Africa, 0038
    • Boehringer Ingelheim Investigational Site
  • Soweto, South Africa, 2000
    • Boehringer Ingelheim Investigational Site
• Spain
  • Badalona, Spain, 08911
    • Hospital Municipal de Badalona
  • Galdakao / Vizcaya, Spain, 48680
    • Hospital de Galdakao
  • Jerez de la Frontera / Cadiz, Spain, 11407
    • Hospital Gral de Jerez de la Frontera
  • L'Hospitalet de Llobregat / Barcelona, Spain, 08902
    • C.A.P. Mosen Cinto Verdaguer
  • Madrid, Spain, 28007
    • Hospital Univ. Gregorio Mara?on
  • Mataro / Barcelona, Spain, 08303
    • C.A.P. Ronda Cerdanya
  • Mostoles / Madrid, Spain, 28935
    • Hospital de Mostoles - Medicina Interna
  • Santiago de Compostela, Spain, 15706
    • Hospital del Conxo
• Sweden
  • Eksjo, Sweden, 575 36
    • Boehringer Ingelheim Investigational Site
  • Karlstad, Sweden, 651 85
    • Boehringer Ingelheim Investigational Site
  • Karlstad, Sweden, 652 24
    • Boehringer Ingelheim Investigational Site
  • Uddevalla, Sweden, 451 40
    • Boehringer Ingelheim Investigational Site
  • Uppsala, Sweden, 751 25
    • Boehringer Ingelheim Investigational Site
• Switzerland
  • Basel, Switzerland, 4031
    • Boehringer Ingelheim Investigational Site
  • Basel, Switzerland, 4051
    • Boehringer Ingelheim Investigational Site
  • Bellinzona, Switzerland, 6500
    • Boehringer Ingelheim Investigational Site
  • St-Imier, Switzerland, 2610
    • Boehringer Ingelheim Investigational Site
  • Vezia, Switzerland, 6940
    • Boehringer Ingelheim Investigational Site
• Taiwan
  • Taipei, Taiwan, 112
    • Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients achieving diastolic blood pressure (DBP) control 24 hours after last dose	at 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in trough seated DBP.	at 6 months
Change from baseline in trough seated systolic blood pressure (SBP)	at 6 months
Proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline ≥10 mmHg)	at 6 months
Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥10 mmHg)	at 6 months
Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥20 mmHg)	at 6 months
Proportion of patients in the trough seated BP category optimal	at 6 months
Proportion of patients in the trough seated BP category normal	at 6 months
Proportion of patients in the trough seated BP category high-normal	at 6 months
Proportion of patients in the trough seated BP category high	at 6 months
Proportion of patients requiring additional antihypertensive therapy to achieve DBP control	at 6 months
Additional reduction in BP by the use of additional antihypertensive therapy	at 6 months
Time to starting additional antihypertensive therapy	within 6 months
Incidence and intensity of Adverse events	6 month
Physical examinations	6 month
Change in laboratory parameters	6 month
12-Lead Electrocardiogramm ECG	6 month
Vital Signs (pulse rate, SBP, DBP)	6 month

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• 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. doi: 10.1517/14656560802707937.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): January 1, 2007
• Study Completion: January 1, 2007

Study Registration Dates

• First Submitted: December 21, 2005
• First Submitted That Met QC Criteria: December 21, 2005
• First Posted (Estimate): December 22, 2005

Study Record Updates

• Last Update Posted (Estimate): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 12, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide; Telmisartan
• Other Study ID Numbers: 502.491