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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00267943
First received: December 21, 2005
Last updated: November 12, 2013
Last verified: November 2013
  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 3

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:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Proportion of patients achieving diastolic blood pressure (DBP) control 24 hours after last dose [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in trough seated DBP. [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in trough seated systolic blood pressure (SBP) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline ≥10 mmHg) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥10 mmHg) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥20 mmHg) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients in the trough seated BP category optimal [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients in the trough seated BP category normal [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients in the trough seated BP category high-normal [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients in the trough seated BP category high [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients requiring additional antihypertensive therapy to achieve DBP control [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Additional reduction in BP by the use of additional antihypertensive therapy [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Time to starting additional antihypertensive therapy [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
  • Incidence and intensity of Adverse events [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Physical examinations [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Change in laboratory parameters [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • 12-Lead Electrocardiogramm ECG [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Vital Signs (pulse rate, SBP, DBP) [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 639
Study Start Date: January 2006
Estimated Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 78 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BIL UK / Ireland
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00267943     History of Changes
Other Study ID Numbers: 502.491
Study First Received: December 21, 2005
Last Updated: November 12, 2013
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
Cardiovascular Diseases
Vascular Diseases
Hydrochlorothiazide
Telmisartan
Telmisartan, hydrochlorothiazide drug combination
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014