Evaluation of Effect of Combination With Telmisartan and Hydrochlorothiazide in Hypertensives Uncontrolled on Amlodipine

NCT00509470 | Completed Phase 4

• 1 other identifier: P2007008
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare depressor effect and safety between combination therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive patients.

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Changes in office blood pressure

  After 12 week treatment

Secondary Outcomes (1)

• 1) Home blood pressure in early morning and before going to bed 2) Changes in uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, fasting plasma glucose (only in diabetic patients), hemoglobin A1c (only in diabetic patients

  After 12 week treatment

Study Arms (2)

telmisartan plus low-dose hydrochlorothiazide

ACTIVE COMPARATOR

12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide

Drug: telmisartan plus hydrochlorothiazide

Amlodipine

ACTIVE COMPARATOR

Amlodipine is continuously administered.

Device: Amlodipine

Interventions

telmisartan plus hydrochlorothiazide DRUG

Combination therapy with telmisartan (40 mg/day) plus hydrochlorothiazide (12.5 mg/day): If blood pressure is not reach to lower than 140/90 mmHg, dose of telmisartan can be increased to 80 mg/day

telmisartan plus low-dose hydrochlorothiazide

Amlodipine DEVICE

Amlodipine

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mg/day of amlodipine is administered for more than 3 months
• Systolic or diastolic blood pressure \>= 140/90 mmHg (more than 2 times measurements at outpatient clinic before start of the study)
• Outpatients

You may not qualify if:

• Secondary hypertension including renovascular hypertension with single kidney or bilateral stenosis
• Administration of antihypertensives other than amlodipine
• Cardiovascular disease (cerebral hemorrhage, cerebral infarction, TIA, angina, myocardial infarction, acute renal failure) occurs less than 6 months before start of the study
• Serum creatinine \>= 2.0 mg/dl
• Severe hypertension (systolic or diastolic blood pressure \>= 180/110 mmHg) or malignant hypertension (hypertensive organ damage is rapidly developing)
• Chronic heart failure (NYHA class\>=III to VI)
• Contraindication of telmisartan or hydrochlorothiazide
• Hyper- (\>= 5.5 mEq/L) or hypo- (\<=3.5 mEq/l) potassemia
• Untreated hyperuricemia or uncontrolled hyperuricemia (serum uric acid \>= 8.0 mg/dl)
• Diabetic patients who require insulin therapy, uncontrolled diabetic patients (hemoglobin A1c \>=9.0%), or patients who possess the risk of hypoglycemic attack
• Patients inadequate for the study

Sponsors & Collaborators

• Tokyo University: lead

Study Sites (1)

Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine

Tokyo, 113-8655, Japan

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Telmisartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Hypertension; 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; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Study Officials

• Toshiro Fujita, MD, PhD

  Professor, Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2007
• First Posted: July 31, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

JP (1)