Effects of Telmisartan by Ambulatory Blood Pressure Monitoring (ABPM) in Chinese Patients With Mild to Moderate Essential Hypertension

NCT02206659 | Completed Phase 3

• 1 other identifier: 502.367
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure monitoring in Chinese patients with mild to moderate essential hypertension

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Mean of trough/peak (T/P) ratio for diastolic blood pressure (DBP) and systolic blood pressure (SBP)

  42 days after start of treatment

• Median of T/P ratio for DBP and SBP

  42 days after start of treatment

Secondary Outcomes (4)

• Change in mean 24-hr DBP and SBP

  Day -13, 42 days after start of treatment

• Change in daytime mean for SBP and DBP

  Day -13, 42 days after start of treatment

• Change in nighttime mean for SBP and DBP

  Day -13, 42 days after start of treatment

• Change in mean of DBP and SBP for last 6-hr dosing interval

  Day -13, 42 days after start of treatment

Study Arms (1)

Telmisartan

EXPERIMENTAL

2-week placebo run-in period followed by 6 weeks of treatment with telmisartan

Drug: Telmisartan; Drug: Placebo

Interventions

Telmisartan DRUG

Telmisartan

Placebo DRUG

Telmisartan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese male or female aged 18 to 75 years
• Mild to moderate hypertension defined as a morning DBP \_95 and \<110 mm Hg at visit1 and visit 2. Mean sitting systolic pressure (SBP) must be \<180 mm Hg
• Ability to provide written informed consent

You may not qualify if:

• Women who are pregnant or breast-feeding, or of childbearing potential without an effective method of birth control (effective birth control methods are: uterine device, surgical sterilisation, progestogens alone)
• Known or suspected secondary hypertension
• Known history of any chronic hepatic disease
• Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant
• New York Heart Association (NYHA) functional class congestive heart failure (CHF) III-IV
• Unstable angina pectoris
• Myocardial infarction or percutaneous transluminal coronary angiography (PTCA) or cardiac surgery within the preceding three months
• Clinical relevant cardiac arrhythmias as determined by the clinical investigator
• Hypertrophic obstructive cardiomyopathy or clinically significant valvular disease
• Evidence of retinal hemorrhages/exudates
• Clinical significant hyperkalemia as defined by serum potassium level \>6.0 milliequivalents (mEq)/L
• Insulin-dependent diabetes mellitus
• Non-insulin-dependent diabetes mellitus with poor glucose control as defined by persistent fasting blood sugar \>200 mg/dl, peripheral neuropathy or autonomic neuropathy
• Known drug or alcohol dependency
• Administration of any diuretic, ACE inhibitor or angiotensin II receptor antagonist within two weeks before run-in period

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 1, 2014
• Study Start: August 1, 2000
• Primary Completion: February 1, 2001
• Last Updated: August 1, 2014

Record last verified: 2014-07