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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00267943
• Collaborator: (none)
• Enrollment: 639
• Locations: 78
• Duration (Months): 12
• Patients Per Site: 8.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: telmisartan 80 mg + hydrochlorothiazide 25 mg	Phase 3

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 Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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.
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Jan 1, 2007
• Study Completion Date: Jan 1, 2007

Outcome Measures

Primary Outcome Measures

1. Proportion of patients achieving diastolic blood pressure (DBP) control 24 hours after last dose [at 6 months]

Secondary Outcome Measures

1. Change from baseline in trough seated DBP. [at 6 months]

2. Change from baseline in trough seated systolic blood pressure (SBP) [at 6 months]

3. Proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline ≥10 mmHg) [at 6 months]

4. Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥10 mmHg) [at 6 months]

5. Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥20 mmHg) [at 6 months]

6. Proportion of patients in the trough seated BP category optimal [at 6 months]

7. Proportion of patients in the trough seated BP category normal [at 6 months]

8. Proportion of patients in the trough seated BP category high-normal [at 6 months]

9. Proportion of patients in the trough seated BP category high [at 6 months]

10. Proportion of patients requiring additional antihypertensive therapy to achieve DBP control [at 6 months]

11. Additional reduction in BP by the use of additional antihypertensive therapy [at 6 months]

12. Time to starting additional antihypertensive therapy [within 6 months]

13. Incidence and intensity of Adverse events [6 month]

14. Physical examinations [6 month]

15. Change in laboratory parameters [6 month]

16. 12-Lead Electrocardiogramm ECG [6 month]

17. Vital Signs (pulse rate, SBP, DBP) [6 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Boehringer Ingelheim Investigational Site	Birker?d		Denmark	3460
2	Boehringer Ingelheim Investigational Site	Haderslev		Denmark	DK-6100
3	Boehringer Ingelheim Investigational Site	Odder		Denmark	8300
4	Boehringer Ingelheim Investigational Site	R?dovre		Denmark	DK-2600
5	Boehringer Ingelheim Investigational Site	Vildbjerg		Denmark	DK-7480
6	Boehringer Ingelheim Investigational Site	Helsinki		Finland	FI-00500
7	Boehringer Ingelheim Investigational Site	Joensuu		Finland	FI-80100
8	Boehringer Ingelheim Investigational Site	Turku		Finland	FI-20100
9	Boehringer Ingelheim Investigational Site	Turku		Finland	FI-20520
10	ALTI	Angers		France	49000
11	Hopital Avicenne	Bobigny		France	93000
12	Mg Recherches	Paris		France	75000
13	Mg Recherches	Paris		France	75015
14	Boehringer Ingelheim Investigational Site	Ellefeld		Germany	08236
15	Boehringer Ingelheim Investigational Site	Florsheim		Germany	65439
16	Boehringer Ingelheim Investigational Site	Frankfurt/Main		Germany	60323
17	Boehringer Ingelheim Investigational Site	Haag		Germany	83527
18	Boehringer Ingelheim Investigational Site	Ingelheim		Germany	55218
19	Boehringer Ingelheim Investigational Site	Nurnberg		Germany	90402
20	Boehringer Ingelheim Investigational Site	Rodgau-Dudenhofen		Germany	63110
21	Boehringer Ingelheim Investigational Site	Unterschneidheim		Germany	73485
22	Boehringer Ingelheim Investigational Site	Hong Kong		Hong Kong
23	Boehringer Ingelheim Investigational Site	Birr		Ireland
24	Boehringer Ingelheim Investigational Site	Carrigallen		Ireland
25	Boehringer Ingelheim Investigational Site	Dublin 18		Ireland
26	Boehringer Ingelheim Investigational Site	Gorey		Ireland
27	Boehringer Ingelheim Investigational Site	Mallow		Ireland
28	Boehringer Ingelheim Investigational Site	New Ross		Ireland
29	Boehringer Ingelheim Investigational Site	Templeshannon		Ireland
30	Ospedale Arnaboldi	Broni (pv)		Italy	27043
31	Azienda Ospedaliera Universita di Ferrara	Ferrara		Italy	44100
32	IRCCS San Raffaele	Roma		Italy	00163
33	Ospedale Civile	Vittorio Veneto (tv)		Italy	31029
34	Boehringer Ingelheim Investigational Site	Incheon		Korea, Republic of	405760
35	Boehringer Ingelheim Investigational Site	Seoul		Korea, Republic of	134701
36	Boehringer Ingelheim Investigational Site	Seoul		Korea, Republic of	152703
37	Boehringer Ingelheim Investigational Site	Kuching, Sarawak		Malaysia	93586
38	Boehringer Ingelheim Investigational Site	Beerzeveld		Netherlands	7685 PG
39	Boehringer Ingelheim Investigational Site	Bennebroek		Netherlands	2121 BB
40	Boehringer Ingelheim Investigational Site	Ewijk		Netherlands	6644 CL
41	Boehringer Ingelheim Investigational Site	Hoogwoud		Netherlands	1817 BG
42	Boehringer Ingelheim Investigational Site	Nijverdal		Netherlands	7441 BN
43	Boehringer Ingelheim Investigational Site	Oude Pekela		Netherlands	9665 AR
44	Boehringer Ingelheim Investigational Site	Oude Pekela		Netherlands	9665 BJ
45	Boehringer Ingelheim Investigational Site	Rijswijk		Netherlands	2281 AK
46	Boehringer Ingelheim Investigational Site	Roelofarendsveen		Netherlands	2371 RB
47	Boehringer Ingelheim Investigational Site	Rotterdam		Netherlands	3082 DC
48	Boehringer Ingelheim Investigational Site	Elverum		Norway	N-2408
49	Boehringer Ingelheim Investigational Site	Moelv		Norway	N-2391
50	Boehringer Ingelheim Investigational Site	Oslo		Norway	N-0369
51	Boehringer Ingelheim Investigational Site	Skedsmokorset		Norway	N-2020
52	Boehringer Ingelheim Investigational Site	Bellville		South Africa	7531
53	Boehringer Ingelheim Investigational Site	Durban		South Africa	4001
54	Boehringer Ingelheim Investigational Site	Lenasia South		South Africa	2033
55	Boehringer Ingelheim Investigational Site	Lenasia		South Africa	2033
56	Boehringer Ingelheim Investigational Site	Midrand		South Africa	1685
57	Boehringer Ingelheim Investigational Site	Newtown		South Africa	2001
58	Boehringer Ingelheim Investigational Site	Pretoria		South Africa	0038
59	Boehringer Ingelheim Investigational Site	Soweto		South Africa	2000
60	Hospital Municipal de Badalona	Badalona		Spain	08911
61	Hospital de Galdakao	Galdakao / Vizcaya		Spain	48680
62	Hospital Gral de Jerez de la Frontera	Jerez de la Frontera / Cadiz		Spain	11407
63	C.A.P. Mosen Cinto Verdaguer	L'Hospitalet de Llobregat / Barcelona		Spain	08902
64	Hospital Univ. Gregorio Mara?on	Madrid		Spain	28007
65	C.A.P. Ronda Cerdanya	Mataro / Barcelona		Spain	08303
66	Hospital de Mostoles - Medicina Interna	Mostoles / Madrid		Spain	28935
67	Hospital del Conxo	Santiago de Compostela		Spain	15706
68	Boehringer Ingelheim Investigational Site	Eksjo		Sweden	575 36
69	Boehringer Ingelheim Investigational Site	Karlstad		Sweden	651 85
70	Boehringer Ingelheim Investigational Site	Karlstad		Sweden	652 24
71	Boehringer Ingelheim Investigational Site	Uddevalla		Sweden	451 40
72	Boehringer Ingelheim Investigational Site	Uppsala		Sweden	751 25
73	Boehringer Ingelheim Investigational Site	Basel		Switzerland	4031
74	Boehringer Ingelheim Investigational Site	Basel		Switzerland	4051
75	Boehringer Ingelheim Investigational Site	Bellinzona		Switzerland	6500
76	Boehringer Ingelheim Investigational Site	St-Imier		Switzerland	2610
77	Boehringer Ingelheim Investigational Site	Vezia		Switzerland	6940
78	Boehringer Ingelheim Investigational Site	Taipei		Taiwan	112

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim Study Coordinator, BIL UK / Ireland

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00267943
• Other Study ID Numbers: 502.491
• First Posted: Dec 22, 2005
• Last Update Posted: Nov 13, 2013
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Hypertension; Hydrochlorothiazide; Telmisartan

Study Results

No Results Posted as of Nov 13, 2013