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

NCT00257491 | Completed Phase 3

• 1 other identifier: 502.488
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

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.

Interventions

Telmisartan DRUG

Telmisartan/HCTZ DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Participants between 18 and 80 years of age.
• Ability to provide written informed consent. 4.24 hour mean DBP \>= 85 mmHg at visit 3.
• Ability to stop any current antihypertensive therapy without risk to the patient (investigators discretion).

You may not qualify if:

• Patients taking more than three anti-hypertensive medications at the screening visit.
• 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.
• Any woman:
• Who has a positive urine pregnancy test at screening (Visit 1).
• Who is nursing.
• 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.
• Clinically relevant hypokalaemia or hyperkalaemia.
• Uncorrected volume depletion.
• Uncorrected sodium depletion.
• Hereditary fructose intolerance.
• Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim Shanghai

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 23, 2005
• Study Start: November 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: November 11, 2013

Record last verified: 2013-11

Locations

CN (1)