ADDM Study - Amtrel and Co-Diovan in Type 2 Diabetes Mellitus Hypertension Patients With Microalbuminuria

June 16, 2011 updated by: TSH Biopharm Corporation Limited

Efficacy and Safety of Two Fixed-combination Antihypertensive Regimens, Amtrel® and Co-Diovan® in Type 2 Diabetes Hypertension Patients With Microalbuminuria

The purpose of the study is to compare the change from baseline in blood pressures (DBP/SBP) to 16-week regimen between Amtrel® and Co-Diovan®. The secondary objectives were listed as the following.

  • To compare the response rate (defined as SBP < 130 mmHg and DBP < 80 mmHg) at the end of study
  • To evaluate the change from baseline in albumin-to-creatinine ratio with antihypertensive medications in whole group (combined treatment groups) and each treatment group (Amtrel®, Co-Diovan®) at Week 16
  • The change from baseline in glycosylated hemoglobin (HbA1c) at Week 16
  • The change from baseline in fasting plasma glucose (FPG) at Week 16
  • The change from baseline in fasting lipid profiles (triglyceride, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) at Week 16
  • The change from baseline in arteriosclerosis marker (brachial-ankle pulse-wave velocity (ba-PWV) and ankle-brachial pressure index (ABI), using Colin-VP1000) at Week 16
  • The change from baseline on the body mass index (BMI) and waist-hip ratio (WHR) at each specified study time point
  • To ascertain the safety and tolerability of Amtrel® versus Co-Diovan® including AE/SAE, and laboratory examinations

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At the screening visit, patients who fulfilled the entrance criteria and had given written informed consent entered a placebo running period where they discontinued antihypertensive medication for two weeks. During that period, Adalat 5mg could be given for emergency. At the end of placebo running period those patients became hypertensive (i.e., SBP between 130-180mmHg or DBP between 80-110mmHg) were randomized into either treatment group. For those patients remaining normotensive continued to be on placebo run-in for another two weeks (10 - 14 days). After the two-week (10 - 14 days) placebo run-in period those patients became hypertensive were randomized into either treatment group. However for those patients remaining normotensive were excluded from the study. After randomization into either arm, patients entered four months treatment period. The dosage adjustment were proceed in order to reach the best effect. During the treatment period there was a monthly visit to assess the response of the patients.

The starting dose of Amtrel® was 1 capsule (contains 1/2 tablet) (amlodipine / benazepril hydrochloride 2.5 mg/ 5 mg) every morning and could be adjusted up to 2 capsules (contains 1 tablet per capsule) (amlodipine / benazepril hydrochloride 10 mg/ 20 mg) every morning if patients did not achieve the criteria of SBP<130 mmHg and DBP< 80 mmHg during treatment period.

The starting dose of Co-Diovan® was 1 capsule (contains 1/2 tablet) (valsartan/ hydrochlorothiazide 40 mg/ 6.25 mg) every morning and could be adjusted up to 2 capsules (contains 1 tablet per capsule) (valsartan/ hydrochlorothiazide 160 mg/ 25.0 mg) every morning if patients did not achieve the criteria of SBP<130 mmHg and DBP< 80 mmHg during treatment period.

All randomized patients attended monthly clinic visits for the 16-week treatment period. At week 4 (Visit 3), all patients were force-titrated to 1 capsule (1 tablet per capsule) for 4 weeks. Subsequently, those patients did not achieve the target blood pressure (SBP<130 mmHg and DBP<80 mmHg) were titrated monthly to next dose level (2 capsule per day).

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Chang Gung Memorial Hospital-KaohSiung
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital
      • Taipei, Taiwan, 220
        • Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 2 diabetes with stable controlled (HbA1c between 6.5-10%)
  • SBP between 130-180mmHg or DBP between 80-110mmHg
  • microalbuminuria (UAE 30-300mg/24hrs or creatinine 30-300mg/g)

Exclusion Criteria:

  • IDDM or secondary forms of diabetes
  • hepatic and/or renal dysfunction
  • serum potassium level > 5.5mmol/L
  • severe renal disease
  • Chronic Heart Failure (NYHA class III or IV)
  • unstable CV disease
  • PTCA within 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Co-Diovan® Group
The starting dose of Co-Diovan® was 1 capsule (contains 1/2 tablet) (valsartan/ hydrochlorothiazide 40 mg/ 6.25 mg) every morning and could be adjusted up to 2 capsules (contains 1 tablet per capsule) (valsartan/ hydrochlorothiazide 160 mg/ 25.0 mg) every morning if patients did not achieve the criteria of SBP<130 mmHg and DBP< 80 mmHg during treatment period
Drug: Valsartan+Hydrochlorothiazide
Valsartan 80 mg + Hydrochlorothiazide 12.5 mg, daily use and forced titrate till 16-week end
Other Names:
  • Co-Diovan®
EXPERIMENTAL: Amtrel® Group
The starting dose of Amtrel® was 1 capsule (contains 1/2 tablet) (amlodipine / benazepril hydrochloride 2.5 mg/ 5 mg) every morning and could be adjusted up to 2 capsules (contains 1 tablet per capsule) (amlodipine / benazepril hydrochloride 10 mg/ 20 mg) every morning if patients did not achieve the criteria of SBP<130 mmHg and DBP< 80 mmHg during treatment period
Drug: Amlodipine+Benazepril
Amlodipine besylate 5 mg + Benazepril hydrochloride 10 mg, daily use and forced titrate till 16-week end
Other Names:
  • Amtrel®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the change from baseline in blood pressures (DBP/SBP) to 16-week regimen between Amtrel® and Co-Diovan®
Time Frame: 16-week
16-week

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the response rate (defined as SBP < 130 mmHg and DBP < 80 mmHg) at the end of study
Time Frame: 16-week
16-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TSH Biopharm Corporation Limited

Investigators

  • Principal Investigator: Wayne H-H Sheu, Taichung Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

June 15, 2011

First Submitted That Met QC Criteria

June 16, 2011

First Posted (ESTIMATE)

June 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2011

Last Update Submitted That Met QC Criteria

June 16, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTY-ABM-0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Valsartan+Hydrochlorothiazide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe