Combination of Telmisartan 80mg Plus Hydrochlothiazide 12.5mg to Telmisartan 80mg in Patients Failed in Telmisartan 80mg
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Telmisartan/HCTZ (Drug); Telmisartan (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Shanghai
Summary
To demonstrate that a fixed dose combination of telmisartan 80 mg plus HCTZ 12. 5 mg is
superior to t elmisartan 80 mg alone in patients, who fail to respond adequately to
telmisartan 80 mg monotherapy, in lowering seated trough diastolic blood pressure after eight
weeks of treatment.
Clinical Details
Official title: Safety & Efficacy of MicardisPlus 80/12.5
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary efficacy variable is change from baseline in seated DBP at trough (24 hours post-dosing) after eight weeks of randomized treatment or at last trough observation during the double-blind phase (i.e. last trough observation carried forward).
Secondary outcome: Change from baseline in seated SBP, standing DBP and SBP at trough after eight weeks of randomized treatment or at last trough observation during the double-blind phase. The percentage of patients responding to the treatment. Sfaty.
Detailed description:
This is a multi-centre, prospective, randomized, double-blind, parallel-group study in
approximately 244 patients with a history of mild-to-moderate hypertensive who have been
shown not to respond to telmisartan monotherapy. All patients will enter a one-week screening
phase prior to starting the eight-week open-label T80 m g period. At end of four weeks only
patients who fail to respond to T80 mg (DBP '>='90 mm Hg) will co ntinue the treatment with
T80 mg for another four weeks. At the end of eight weeks, only patients w ho fail to respond
to T80 mg (DBP '>=' 90 mm Hg) will be randomized, double-blind, to receive either T 80 mg
alone or the fixed dose combination of T80 mg plus HCTZ 12. 5 mg for eight weeks. Seated BP
wi ll be taken 24 hours post-dose at each visit. Labs, ECG, and physical examination will be
done at s creening, at baseline and at the final visit.
Study Hypothesis:
The primary objective of the study, showing that fixed dose combination is super ior to
telmisartan 80 mg alone will be tested using the hypotheses given below. H0 : u T80/H12. 5 - uT80 = 0 mm Hg vs H1 : uT80/H12. 5 - uT80 not equal 0 mm Hg, where uT80/H12. 5 anduT80
represent the average reduction from baseline (Visit 4) in trough seated DBP for the fixed
dose combination and telmisartan 80 mg, resp ectively. Testing of the null hypothesis will be
performed using a two-sided test of signi ficance at an a-level (type-I error rate) of 0. 05.
Comparison(s):
The primary efficacy endpoint will be the change from baseline in seated DBP 24 hours
post-dose at the last visit duirng the double-blind treatment phase. The pre-dose
measurement on visit 4 will be viewed as the baseline measurement.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
1. History of mild-to-moderate hypertension defined by a mean seated DBP >=95 and <=109mmHg
before inclusion in the open-label phase 2. Patients who fail to respond adequately to
telmisartan monotherapy (mean seated DBP>=90 mmHg ) 3. Participants between 18 and 80
years of age 4. Ability to provide written informed consent Exclusion Criteria
1. Patients taking more than three anti-hypertensive medications at the screening visit.
2. Pre-menopausal women (last menstruation 1 year prior to start of screening):
1. Who are not surgically sterile (hysterectomy, tubal ligation)
2. Who are NOT practicing acceptable means of birth control or who do NOT plan to
continue using an acceptable method throughout the study. Acceptable methods of
birth control include IUD, oral, implantable or injectable contraceptives
3. Any woman:
1. Who has a positive urine pregnancy test at screening (Visit 1)
2. Who is nursing
4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
1. SGPT(ALT) or SGOT(AST) greater than two times the upper limit of normal
2. Serum creatinine >3. 0 mg/dL (or 265mol/L) or creatinine clearance <0. 6 ml/sec
5. Clinically relevant hypokalaemia or hyperkalaemia
6. Uncorrected volume depletion
7. Uncorrected sodium depletion
8. Primary aldosteronism
9. Hereditary fructose intolerance
10. Biliary obstructive disorders, cholestatis or moderate to severe hepatic
insufficiency
11. Known or suspected secondary hypertension
12. Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney;
post-renal transplant patients, presence of only one functioning kidney
13. Congestive heart failure (NYHA functional class CHF III-IV
14. Unstable angina within the past three months
15. Stroke within the past six months
16. Myocardial infarction or cardiac surgery within the past three months
17. PTCA within the past three months
Locations and Contacts
Ruijin Hospital, School of Medicine, Shanghai 200025, China
No. 1 Hospital Affiliated Nanjing, Nanjing 210006, China
No. 1 Hosp Affiliated to Med College, Zhejiang Province 310003, China
Peking Union Medical College Hospital, Beijing 100730, China
China-Japan Friendship Hospital, Beijing 100029, China
Beijing Tiantan Hospital, Beijing 100050, China
Second Hospital Affiliated to Tianjin Med University, Tianjin 300211, China
Shanghai Changhai Hospital, Shanghai 200433, China
254 PLA Hospital, Tianjin 300150, China
Additional Information
Ending date: September 2006
Last updated: April 4, 2008
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