PROBE Investigation of the Safety & Efficacy of Telmisartan (Micardis®) vs Ramipril (Altace®) Using ABPM in HTN

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT00274599

Collaborator

(none)

812

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

Demonstrate that telmisartan 80mg was at least as effective and possibly superior to ramipril 5mg & 10mg in lowering mean ambulatory DBP and SBP during the last 6 hrs of the 24-hr dosing interval in mild-to-moderate hypertensives at the end of 8 and 14 week treatment phases.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Telmisartan Drug: Ramipril	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

812 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group, Multicentre, Forced-Titration, 14-Week Treatment Study Comparing MICARDIS® (Telmisartan 40-80-80 mg, QD) and ALTACE® (Ramipril 2.5-5-10 mg, QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring

Study Start Date :

Oct 1, 2002

Actual Primary Completion Date :

Dec 1, 2003

Outcome Measures

Primary Outcome Measures

Change from baseline in the last 6-hr mean DBP & SBP as measured by ABPM at the end of and 8-wk treatment period (T80 vs R5 mg) and 14-wk treatment period (T80 vs R10 mg) []

Secondary Outcome Measures

Change from baseline in last 6-hr ABPM mean for: pulse pressure; DBP, SBP and PP; DBP/SBP/PP in the morning, daytime and nighttime periods of the 24-hr dosing interval; Change from baseline in mean, seated, trough DBP & SBP measured by manual cuff []

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Contacts and Locations

Locations

	Site	City	State	Country
1	Boehringer Ingelheim Investigational Site	Birmingham	Alabama	United States
2	Boehringer Ingelheim Investigational Site	Phoenix	Arizona	United States
3	Boehringer Ingelheim Investigational Site	Tuscon	Arizona	United States
4	Harold B. Betton, M.D.	Little Rock	Arkansas	United States
5	Attn: Ginger Paselk	Long Beach	California	United States
6	Boehringer Ingelheim Investigational Site	Los Angeles	California	United States
7	Boehringer Ingelheim Investigational Site	Orange	California	United States
8	Boehringer Ingelheim Investigational Site	San Diego	California	United States
9	Boehringer Ingelheim Investigational Site	Santa Ana	California	United States
10	Boehringer Ingelheim Investigational Site	Santa Rosa	California	United States
11	Boehringer Ingelheim Investigational Site	Vista	California	United States
12	Boehringer Ingelheim Investigational Site	Hamden	Connecticut	United States
13	Boehringer Ingelheim Investigational Site	Daytona Beach	Florida	United States
14	Boehringer Ingelheim Investigational Site	Ft. Lauderdale	Florida	United States
15	Boehringer Ingelheim Investigational Site	Melbourne	Florida	United States
16	Boehringer Ingelheim Investigational Site	Marietta	Georgia	United States
17	Boehringer Ingelheim Investigational Site	Boise	Idaho	United States
18	Boehringer Ingelheim Investigational Site	Meridian	Idaho	United States
19	Boehringer Ingelheim Investigational Site	Chicago	Illinois	United States
20	Boehringer Ingelheim Investigational Site	Orland Park	Illinois	United States
21	GFI Pharmaceuticals	Evansville	Indiana	United States
22	Boehringer Ingelheim Investigational Site	Newton	Kansas	United States
23	Boehringer Ingelheim Investigational Site	Wichita	Kansas	United States
24	Boehringer Ingelheim Investigational Site	Metarie	Louisiana	United States
25	Boehringer Ingelheim Investigational Site	Auburn	Maine	United States
26	Boehringer Ingelheim Investigational Site	Moorestown	New Jersey	United States
27	Boehringer Ingelheim Investigational Site	Albuquerque	New Mexico	United States
28	Boehringer Ingelheim Investigational Site	East Syracuse	New York	United States
29	Boehringer Ingelheim Investigational Site	White Plains	New York	United States
30	Boehringer Ingelheim Investigational Site	Charlotte	North Carolina	United States
31	Boehringer Ingelheim Investigational Site	Winston Salem	North Carolina	United States
32	Boehringer Ingelheim Investigational Site	Oklahoma City	Oklahoma	United States
33	Boehringer Ingelheim Investigational Site	Portland	Oregon	United States
34	Boehringer Ingelheim Investigational Site	Levittown	Pennsylvania	United States
35	Boehringer Ingelheim Investigational Site	Anderson	South Carolina	United States
36	Spartanburg Medical Research	Spartanburg	South Carolina	United States
37	Boehringer Ingelheim Investigational Site	Dallas	Texas	United States
38	R/D Clinical Research, Inc.	Lake Jackson	Texas	United States
39	Boehringer Ingelheim Investigational Site	Salt Lake City	Utah	United States
40	Boehringer Ingelheim Investigational Site	Lacey	Washington	United States
41	Boehringer Ingelheim Investigational Site	Lakewood	Washington	United States
42	Boehringer Ingelheim Investigational Site	Tacoma	Washington	United States
43	Boehringer Ingelheim Investigational Site	Charleston	West Virginia	United States
44	Boehringer Ingelheim Investigational Site	Calgary	Alberta	Canada
45	Boehringer Ingelheim Investigational Site	Red Deer	Alberta	Canada
46	Boehringer Ingelheim Investigational Site	Conquitlam	British Columbia	Canada
47	Boehringer Ingelheim Investigational Site	Riverview	New Brunswick	Canada
48	Boehringer Ingelheim Investigational Site	St. John	New Brunswick	Canada
49	Boehringer Ingelheim Investigational Site	Bay Roberts	Newfoundland and Labrador	Canada
50	Boehringer Ingelheim Investigational Site	Mount Pearl	Newfoundland and Labrador	Canada
51	Boehringer Ingelheim Investigational Site	St. John's	Newfoundland and Labrador	Canada
52	Boehringer Ingelheim Investigational Site	Halifax	Nova Scotia	Canada
53	Boehringer Ingelheim Investigational Site	Exeter	Ontario	Canada
54	Boehringer Ingelheim Investigational Site	Hastings	Ontario	Canada
55	Boehringer Ingelheim Investigational Site	Kitchener	Ontario	Canada
56	Boehringer Ingelheim Investigational Site	London	Ontario	Canada
57	Boehringer Ingelheim Investigational Site	North York	Ontario	Canada
58	Boehringer Ingelheim Investigational Site	Oakville	Ontario	Canada
59	Boehringer Ingelheim Investigational Site	Orleans	Ontario	Canada
60	205-13085 Yonge St	Richmond Hill	Ontario	Canada
61	155 Ontario Street	St. Catharines	Ontario	Canada
62	Boehringer Ingelheim Investigational Site	Thunder Bay	Ontario	Canada
63	Boehringer Ingelheim Investigational Site	Toronto	Ontario	Canada
64	Boehringer Ingelheim Investigational Site	Weston	Ontario	Canada
65	Boehringer Ingelheim Investigational Site	Windsor	Ontario	Canada
66	Boehringer Ingelheim Investigational Site	Winnipeg	Ontario	Canada
67	Boehringer Ingelheim Investigational Site	Charlottetown	Prince Edward Island	Canada
68	4 rue Robinson Nord	Granby	Quebec	Canada
69	Boehringer Ingelheim Investigational Site	Longueuil	Quebec	Canada
70	Boehringer Ingelheim Investigational Site	Pointe Claire	Quebec	Canada
71	Boehringer Ingelheim Investigational Site	St Leonard	Quebec	Canada
72	725 6E Rue	Val D'Or	Quebec	Canada
73	Boehringer Ingelheim Investigational Site	Regina	Saskatchewan	Canada
74	Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan	Canada

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00274599

Other Study ID Numbers:

502.392

First Posted:

Jan 11, 2006

Last Update Posted:

Nov 8, 2013

Last Verified:

Nov 1, 2013

Additional relevant MeSH terms:

Hypertension

Telmisartan

Ramipril

Study Results

No Results Posted as of Nov 8, 2013