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

NCT00267943 | Completed Phase 3

• 1 other identifier: 502.491
• Study Type: interventional
• Target: 639
• Locations: 16 countries
• Sites: 78

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving diastolic blood pressure (DBP) control 24 hours after last dose

  at 6 months

Secondary Outcomes (17)

• 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

Interventions

telmisartan 80 mg + hydrochlorothiazide 25 mg DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (78)

Boehringer Ingelheim Investigational Site

Birker?d, 3460, Denmark

Location

Boehringer Ingelheim Investigational Site

Haderslev, DK-6100, Denmark

Location

Boehringer Ingelheim Investigational Site

Odder, 8300, Denmark

Location

Boehringer Ingelheim Investigational Site

R?dovre, DK-2600, Denmark

Location

Boehringer Ingelheim Investigational Site

Vildbjerg, DK-7480, Denmark

Location

Boehringer Ingelheim Investigational Site

Helsinki, FI-00500, Finland

Location

Boehringer Ingelheim Investigational Site

Joensuu, FI-80100, Finland

Location

Boehringer Ingelheim Investigational Site

Turku, FI-20100, Finland

Location

Boehringer Ingelheim Investigational Site

Turku, FI-20520, Finland

Location

ALTI

Angers, 49000, France

Location

Hopital Avicenne

Bobigny, 93000, France

Location

Mg Recherches

Paris, 75000, France

Location

Mg Recherches

Paris, 75015, France

Location

Boehringer Ingelheim Investigational Site

Ellefeld, 08236, Germany

Location

Boehringer Ingelheim Investigational Site

Flörsheim, 65439, Germany

Location

Boehringer Ingelheim Investigational Site

Frankfurt am Main, 60323, Germany

Location

Boehringer Ingelheim Investigational Site

Haag, 83527, Germany

Location

Boehringer Ingelheim Investigational Site

Ingelheim, 55218, Germany

Location

Boehringer Ingelheim Investigational Site

Nuremberg, 90402, Germany

Location

Boehringer Ingelheim Investigational Site

Rodgau-Dudenhofen, 63110, Germany

Location

Boehringer Ingelheim Investigational Site

Unterschneidheim, 73485, Germany

Location

Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

Boehringer Ingelheim Investigational Site

Birr, Ireland

Location

Boehringer Ingelheim Investigational Site

Carrigallen, Ireland

Location

Boehringer Ingelheim Investigational Site

Dublin, Ireland

Location

Boehringer Ingelheim Investigational Site

Gorey, Ireland

Location

Boehringer Ingelheim Investigational Site

Mallow, Ireland

Location

Boehringer Ingelheim Investigational Site

New Ross, Ireland

Location

Boehringer Ingelheim Investigational Site

Templeshannon, Ireland

Location

Ospedale Arnaboldi

Broni (pv), 27043, Italy

Location

Azienda Ospedaliera Universita di Ferrara

Ferrara, 44100, Italy

Location

IRCCS San Raffaele

Roma, 00163, Italy

Location

Ospedale Civile

Vittorio Veneto (tv), 31029, Italy

Location

Boehringer Ingelheim Investigational Site

Kuching, Sarawak, 93586, Malaysia

Location

Boehringer Ingelheim Investigational Site

Beerzeveld, 7685 PG, Netherlands

Location

Boehringer Ingelheim Investigational Site

Bennebroek, 2121 BB, Netherlands

Location

Boehringer Ingelheim Investigational Site

Ewijk, 6644 CL, Netherlands

Location

Boehringer Ingelheim Investigational Site

Hoogwoud, 1817 BG, Netherlands

Location

Boehringer Ingelheim Investigational Site

Nijverdal, 7441 BN, Netherlands

Location

Boehringer Ingelheim Investigational Site

Oude Pekela, 9665 AR, Netherlands

Location

Boehringer Ingelheim Investigational Site

Oude Pekela, 9665 BJ, Netherlands

Location

Boehringer Ingelheim Investigational Site

Rijswijk, 2281 AK, Netherlands

Location

Boehringer Ingelheim Investigational Site

Roelofarendsveen, 2371 RB, Netherlands

Location

Boehringer Ingelheim Investigational Site

Rotterdam, 3082 DC, Netherlands

Location

Boehringer Ingelheim Investigational Site

Elverum, N-2408, Norway

Location

Boehringer Ingelheim Investigational Site

Moelv, N-2391, Norway

Location

Boehringer Ingelheim Investigational Site

Oslo, N-0369, Norway

Location

Boehringer Ingelheim Investigational Site

Skedsmokorset, N-2020, Norway

Location

Boehringer Ingelheim Investigational Site

Bellville, 7531, South Africa

Location

Boehringer Ingelheim Investigational Site

Durban, 4001, South Africa

Location

Boehringer Ingelheim Investigational Site

Lenasia, 2033, South Africa

Location

Boehringer Ingelheim Investigational Site

Lenasia South, 2033, South Africa

Location

Boehringer Ingelheim Investigational Site

Midrand, 1685, South Africa

Location

Boehringer Ingelheim Investigational Site

Newtown, 2001, South Africa

Location

Boehringer Ingelheim Investigational Site

Pretoria, 0038, South Africa

Location

Boehringer Ingelheim Investigational Site

Soweto, 2000, South Africa

Location

Boehringer Ingelheim Investigational Site

Incheon, 405760, South Korea

Location

Boehringer Ingelheim Investigational Site

Seoul, 134701, South Korea

Location

Boehringer Ingelheim Investigational Site

Seoul, 152703, South Korea

Location

Hospital Municipal de Badalona

Badalona, 08911, Spain

Location

Hospital de Galdakao

Galdakao / Vizcaya, 48680, Spain

Location

Hospital Gral de Jerez de la Frontera

Jerez de La Frontera / Cadiz, 11407, Spain

Location

C.A.P. Mosen Cinto Verdaguer

L'Hospitalet de Llobregat / Barcelona, 08902, Spain

Location

Hospital Univ. Gregorio Mara?on

Madrid, 28007, Spain

Location

C.A.P. Ronda Cerdanya

Mataro / Barcelona, 08303, Spain

Location

Hospital de Mostoles - Medicina Interna

Mostoles / Madrid, 28935, Spain

Location

Hospital del Conxo

Santiago de Compostela, 15706, Spain

Location

Boehringer Ingelheim Investigational Site

Eksjö, 575 36, Sweden

Location

Boehringer Ingelheim Investigational Site

Karlstad, 651 85, Sweden

Location

Boehringer Ingelheim Investigational Site

Karlstad, 652 24, Sweden

Location

Boehringer Ingelheim Investigational Site

Uddevalla, 451 40, Sweden

Location

Boehringer Ingelheim Investigational Site

Uppsala, 751 25, Sweden

Location

Boehringer Ingelheim Investigational Site

Basel, 4031, Switzerland

Location

Boehringer Ingelheim Investigational Site

Basel, 4051, Switzerland

Location

Boehringer Ingelheim Investigational Site

Bellinzona, 6500, Switzerland

Location

Boehringer Ingelheim Investigational Site

Saint-Imier, 2610, Switzerland

Location

Boehringer Ingelheim Investigational Site

Vezia, 6940, Switzerland

Location

Boehringer Ingelheim Investigational Site

Taipei, 112, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 19191674 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Study Officials

• Boehringer Ingelheim Study Coordinator

  BIL UK / Ireland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 21, 2005
• First Posted: December 22, 2005
• Study Start: January 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

NO (4); IE (7); KR (3); IT (4); MY (1); CH (5); FR (4); TW (1); ZA (8); FI (4); NL (10); DE (8); ES (8); SE (5); HK (1); DK (5)