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

This study has been completed.
Sponsor:
Information provided by:
TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier:
NCT01375322
First received: June 15, 2011
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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

Condition Intervention Phase
Hypertension
Diabetes Mellitus, Type 2
Albuminuria
Drug: Amlodipine+Benazepril
Drug: Valsartan+Hydrochlorothiazide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Two Fixed-combination Antihypertensive Regimens, Amtrel® and Co-Diovan® in Type 2 Diabetes Hypertension Patients With Microalbuminuria

Resource links provided by NLM:


Further study details as provided by TSH Biopharm Corporation Limited:

Primary Outcome Measures:
  • To compare the change from baseline in blood pressures (DBP/SBP) to 16-week regimen between Amtrel® and Co-Diovan® [ Time Frame: 16-week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the response rate (defined as SBP < 130 mmHg and DBP < 80 mmHg) at the end of study [ Time Frame: 16-week ] [ Designated as safety issue: No ]

Enrollment: 226
Study Start Date: June 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Amtrel®

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).

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375322

Locations
Taiwan
Chang Gung Memorial Hospital-Kaohsiung
Kaohsiung, Taiwan, 833
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Tri-Service General Hospital
Taipei, Taiwan, 114
Far Eastern Memorial Hospital
Taipei, Taiwan, 220
Sponsors and Collaborators
TSH Biopharm Corporation Limited
Investigators
Principal Investigator: Wayne H-H Sheu Taichung Veterans General Hospital
  More Information

No publications provided by TSH Biopharm Corporation Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Owen Chen/Clinical Research Manager, TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier: NCT01375322     History of Changes
Other Study ID Numbers: TTY-ABM-0601
Study First Received: June 15, 2011
Last Updated: June 16, 2011
Health Authority: Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Benazepril
Valsartan
Antihypertensive Agents
Hydrochlorothiazide
Amlodipine
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Vasodilator Agents

ClinicalTrials.gov processed this record on April 14, 2014