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CompletedNCT00257491Updated Nov 11, 2013

Study to Evaluate the Trough and Peak Effect of Once Daily Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg (Micardis Plus) by Ambulatory Blood Pressure Monitoring (ABPM) in Patients With Mild to Moderate Essential Hypertension

A Phase 3 interventional study of Telmisartan and Telmisartan/HCTZ in Hypertension, sponsored by Boehringer Ingelheim. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-11-11.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
29
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To evaluate the trough and peak effect of once daily MICARDIS PLUS (Telmisartan 80 mg/hydrochlorothiazide 12.5 mg) by 24 ABPM in patients with mild to moderate essential hypertension.

Read the detailed description

This study is designed as an open label study. After a 2-week placebo run-in phase, qualified patients will be administered with telmisartan 80mg for 2 weeks, then forcefully titrated to telmisartan 80 mg and hydrochlorothiazide 12.5 mg fixed dose combination for 6 weeks. 24 hour ABPM will be performed at the end of placebo run-in period (baseline) and after 8 weeks of active treatment.

Study Hypothesis:

The primary analyses will be the calculation of trough to peak ratios (T/P ratios) for DBP and SBP. The T/P ratio will be calculated on the basis of changes in hourly means (related to dosing time) from baseline (DeltaHM). Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. Thus, T/P is calculated as T/P = mean(DeltaHM22 - DeltaHM24)/min (DeltaHM2 - DeltaHM8).

Comparison(s):

To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension.

02

Conditions studied

03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 29 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. History of mild-to-moderate essential hypertension defined by a mean seated DBP >= 95 and \<= 109 mmHg, and SBP \< 180mmHg measured by manual cuff sphygmomanometer at visit 2.

    Note: The manual cuff value is calculated as the mean of three seated measurements collected 2 minutes apart, after the patient has been seated quietly for 5 minutes. For calculation of mean values by the investigator, decimal places should be rounded to integers as usual (e.g., a DBP of 94.7 would be rounded to 95 mmHg and a DBP of 109.3 would be rounded to 109 mmHg).

  2. Participants between 18 and 80 years of age.
  3. Ability to provide written informed consent. 4.24 hour mean DBP >= 85 mmHg at visit 3.

5.Ability to stop any current antihypertensive therapy without risk to the patient (investigators discretion).

Exclusion criteria

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):

    • Who are not surgically sterile (hysterectomy, tubal ligation).
    • 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:

    • Who has a positive urine pregnancy test at screening (Visit 1).
    • Who is nursing.
  4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

    • SGPT(ALT) or SGOT(AST) greater than two times the upper limit of normal.
    • Serum creatinine > 3.0 mg/dL (or 265 mmol/L) or creatinine clearance \< 0.6 ml/sec.
  5. Clinically relevant hypokalaemia or hyperkalaemia.
  6. Uncorrected volume depletion.
  7. Uncorrected sodium depletion.
  8. Hereditary fructose intolerance.
  9. Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency.
  10. Known or suspected secondary hypertension.
  11. Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney.
  12. Congestive heart failure (NYHA functional class CHF III-IV refer to Appendix 11. 1).
  13. Unstable angina within the past three months.
  14. Stroke within the past six months.
  15. Myocardial infarction or cardiac surgery within the past three months.
  16. PTCA within the past three months.
  17. Patients who have previously experienced symptoms characteristic of angiodema during treatment with ACE inhibitor or angiotensin II receptor antagonists.
  18. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
  19. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Interventions

  • DrugTelmisartan
  • DrugTelmisartan/HCTZ
06

What researchers measure

Primary outcomes

  1. To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension.

Secondary outcomes

  1. Smooth Index for DBP and SBP Change from the baseline in the ABPM endpoint: 24 hour mean, daytime mean , nighttime mean, morning mean, last 6-hours of the dosing interval mean SBP, DBP,MAP and HR.

07

Study locations

1 site
  • Shanghai Ruijin Hospital
    Shanghai, 200025, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00257491
Lead sponsor
Boehringer Ingelheim
First posted
Nov 23, 2005
Start date
Nov 2005
Primary completion
Aug 2006
Completion
Aug 2006
Last update
Nov 11, 2013

Study contacts

Boehringer Ingelheim Study Coordinator
study chair · Boehringer Ingelheim Shanghai
View the source record on ClinicalTrials.gov ↗

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