Brief Summary

1.To investigate the dose response of the combination therapy, Telmisartan and Hydrochlorothiazide for the Japanese patients with Essential Hypertension.
2.To compare this dose response with that in the US study.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

583

participants targeted

Target at P75+ for phase_2 hypertension

Timeline

Completed

Started Jun 2004

Geographic Reach

1 country

24 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

June 1, 2004

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed

Last Updated

November 8, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

September 9, 2005

Last Update Submit

November 7, 2013

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

Change from baseline in supine diastolic blood pressure (DBP) at trough (24 hours post-dose)
after 8 weeks

Secondary Outcomes (6)

Change in supine systolic blood pressure (SBP) at trough (24 hours post-dose)
after 8 weeks
Change in sitting systolic and diastolic blood pressure at trough (24 hours post-dose)
after 8 weeks
DBP control rate
after 8 weeks
DBP response rate
after 8 weeks
SBP response rate
after 8 weeks
+1 more secondary outcomes

Interventions

TelmisartanDRUG

HydrochlorothiazideDRUG

Telmisartan + HydrochlorothiazideDRUG

Eligibility Criteria

Age20 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Essential hypertensive patients who meet the following criteria:
Mean supine DBP \>= 95 and \<= 114 mm Hg at each of Visits 2 and 3.
Mean supine DBP must not vary by more than 10 mm Hg between Visit 2 and Visit 3.
Mean supine systolic blood pressure (SBP) must be \>= 140 and \<= 200 mm Hg at Visit 3.
(The mean DBP and SBP values are calculated as the mean of the three supine measurements taken two minutes apart.)
Male or female.
Age \>= 20 and Age \<= 80 years.
Outpatient.
Able to stop current antihypertensive therapy without risk to the patient.
Ability to provide written Informed Consent in accordance with ?Good Clinical Practice (GCP)? (MHW Ordinance No. 28, as of Mar. 27, 1997) and the local legislation.

You may not qualify if:

Known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, melanocytoma, etc.).
Mean supine DBP \> 114 mmHg and/or mean supine SBP \> 200 mmHg during any visit of the placebo run-in period.
Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias (atrioventricular conduction disturbance (grade II - III), atrial fibrillation etc.).
NYHA functional class heart failure III-IV.
Myocardial infarction or cardiac surgery within 6 months of signing the informed consent form.
Coronary artery bypass surgery or percutaneous transluminal coronary angioplasty (PTCA) within 3 months of signing the informed consent form.
Unstable angina within 3 months of signing the informed consent form.
Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
Stroke or transient ischemic attack within 6 months of signing the informed consent form.
History of sudden exacerbation of renal function with AT1 receptor antagonists or ACE inhibitors; post-renal transplant.
Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, laryngeal swelling with dyspnea) during treatment with AT1 receptor antagonists or ACE inhibitors.
Known hypersensitivity to any component of the formulation, or a known hypersensitivity to sulfonamides or sulphonamide-derived drugs (e.g. thiazides).
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
SGPT(ALT) or SGOT(AST) \>= 2 times the upper limit of normal at screening (Visit 1).
Patients who have markedly poor bile secretion by the following laboratory parameters: Patients whose direct bilirubin \>= 2.0 mg/dL at screening (Visit 1).
+1 more criteria

Contact the study team to confirm eligibility.