Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study compares the antihypertensive effects between different treatment groups including antihypertensive drug, anxiolytic, and both, which provide a new clinical evidence for controlling blood pressure in patients with hypertension and anxiety.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chongqing Medical University
• Treatments: Amlodipine; Tandospirone

Criteria

Inclusion Criteria:

1. An age of 60 - 80 years old;

2. Mild or moderate hypertension diagnosed in previous or at screening (office systolic blood pressure ≥ 140 mm Hg and ≤ 180 mm Hg, or diastolic blood pressure ≥ 90 mm Hg and ≤ 110 mm Hg, or both, on three readings on separate days when not taking any blood pressure drugs) ,and the blood pressure still meet the above criteria after the run-in period;

3. A total score ≥ 14 and ≤ 24 on the Hamilton Anxiety Scale (HAMA), except for panic disorder;

4. Informed consent signed.

Exclusion Criteria:

1. Secondary hypertension;

2. Office systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≤ 110 mm Hg

3. Hypertension with target organ damage;

4. Cerebral hemorrhage, ischemic cerebral infarction, coronary artery disease, myocardial infarction, second-degree or third-degree atrioventricular block, sick sinus syndrome, atrial fibrillation, left ventricular hypertrophy, cardiac insufficiency (NYHA class Ⅱ-Ⅳ);

5. Diabetes and dyslipidemia;

6. Asthma, chronic obstructive pulmonary disease, bronchiectasis, and respiratory failure;

7. Inflammatory bowel disease, active gastritis, pancreatitis, partial or complete intestinal obstruction, and chronic diarrhea;

8. Acute or chronic hepatitis, hepatic insufficiency (ALT or AST is more than 2 times the upper limit of normal), and renal insufficiency (serum creatinine > 130 umol / L);

9. Uncontrolled thyroid diseases;

10. Severe or unstable central nervous system diseases;

11. Schizophrenia, bipolar disorder, severe intellectual disability, or severe cognitive impairment;

12. Having been diagnosed with alcohol or drug abuse within the past 1 year;

13. Presenting the risk of suicide, self-injury, and hurt others;

14. Having participated in other clinical studies within the past 3 months;

15. Having been treated with anxiolytics, antidepressants, antipsychotics within the past 4 weeks, or have contraindications to the study medications.

16. Breastfeeding, pregnancy, or a pregnancy plan during the study;

17. Other diseases which the responsible clinician judged that a change in current therapy would place the participant at risk.