Trial Condition(s):

Hypertension

Low-dose Nifedipine-Valsartan Combination compared to up-titrated Valsartan monotherapy in essential hypertension

Bayer Identifier:

14511

ClinicalTrials.gov Identifier:

NCT00993109

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This will be a multi-center, prospective, randomized, open-label, parallel design, two arm comparator trial. In the proposed study, the investigators will compare low-dose combination therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with respect to their blood pressure-decreasing effects in patients with essential hypertension.The study consists of a screening visit, followed by randomization and administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or Valsartan 160 mg for 12 weeks of treatment.The primary efficacy parameters will be mean SBP and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.

Inclusion Criteria
- Men and women aged 18 - 75 years
 - Essential hypertension not well controlled by current low dose (80 mg) valsartan monotherapy for at least 4 weeks. Patients on prior treatment with monotherapy diuretic, ACE-I or beta blocker or an ARB other  than valsartan and switched to the current low dose valsartan 80 mg monotherapy for at least 4 weeks are also eligible, provided the hypertension is still not well controlled.
 - Office systolic blood pressure (sitting) >140 mmHg (sitting for >/= 5 min., no cigarettes and/or coffee/tea for >/=30 min. before BP measurement).
 -  BMI <33 kg/m2
Exclusion Criteria
- Participation in any clinical investigational drug study within the previous 12 weeks 
 - Concomitant treatments with: 
1. Any anti-hypertensive treatment other than Valsartan 80 mg
2. Cytochrome P450-3A4 inhibitors or inducers 
3. Potassium-sparing diuretics
 - Severe hypertension (DBP >/= 110 mm Hg and/or SBP >/= 180 mm Hg) and/or evidence of secondary forms of hypertension  
 - Any of the following cardiovascular diseases:
 - History of cardiovascular shock
 - Myocardial infarction or unstable angina within the previous 6 months
 - Severe cardiac valve disease
 - Past or present severe rhythm or conduction disorder.
 - Cerebrovascular ischemic event and/or history of intracerebral hemorrhage or subarachnoid hemorrhage (SAH) within the previous 12 months
 - Type 1 or 2 diabetes mellitus
 - Proteinuria 
 - Uncorrected hypokalemia or hyperkalemia, sodium depletion and/or hypovolemia
 - Gastrointestinal disease resulting in the potential for malabsorption and/or severe gastro-intestinal tract narrowing; kock pouch (ileostomy after proctocolectomy)
 - Cholestasis or biliary obstruction
 - Liver disease or aspartate aminotransferase (AST) / alanine aminotransferase (ALT) levels >3 x upper limits of normal (ULN)
 - Renal failure, creatinine level >2.0 mg/dl

Trial Summary

Enrollment Goal
360
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Adalat GITS (Nifedipine, BAYA1040)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School

Shanghai, China, 200025

Status
Completed
 
Locations

The First hospital of China Medical University

Shenyang, China, 110001

Status
Terminated
 
Locations

1st Affiliated Hosp., of Nanjing Medical Univ.

Nanjing, China, 210029

Status
Completed
 
Locations

The Third Xiangya Hospital of Central South University

Changsha, China, 410013

Status
Completed
 
Locations

Seoul St. Mary's Hospital

Seoul, South Korea, 110-744

Status
Completed
 
Locations

Pusan National University Hospital

Yangsan-si, South Korea

Status
Completed
 
Locations

Chungnam National University Hospital

Jung-gu, South Korea

Status
Completed
 
Locations

Chonnam National University Hospital

Donggu,, South Korea, 501757

Status
Completed
 
Locations

China-Japan Friendship Hospital

Beijing, China, 100029

Status
Completed
 
Locations

Cardiovascular Institute and Fuwai Hospital, CAMS & PUMC

Beijing, China, 100037

Status
Completed
 
Locations

The Xiangya Hospital of Central South University

Changsha, China, 410008

Status
Completed
 
Locations

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China, 510080

Status
Completed
 
Locations

People's Hospital of Hebei Province

Shijiazhuang, China, 050051

Status
Completed
 
Locations

Drum Tower Hospital of Nanjing University Medical School

Nanjing, China, 210008

Status
Completed
 
Locations

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea, 120-752

Status
Completed
 
Locations

Seoul National University Hospital

Jongno-gu, South Korea

Status
Completed
 
Locations

The Catholic University of Korea Kangnam St. Mary's Hospital

Bucheon-si,, South Korea

Status
Completed
 

Trial Design